{"id":21989,"date":"2025-11-27T19:54:35","date_gmt":"2025-11-27T22:54:35","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/us-denovo\/"},"modified":"2026-02-09T17:11:06","modified_gmt":"2026-02-09T20:11:06","slug":"us-denovo","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/","title":{"rendered":"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"21989\" class=\"elementor elementor-21989 elementor-21951\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c70932e e-flex e-con-boxed e-con e-parent\" data-id=\"c70932e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9082f09 e-con-full e-flex e-con e-child\" data-id=\"9082f09\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-438e722 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"438e722\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png\" class=\"attachment-full size-full wp-image-4678\" alt=\"Logo Sobel\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png 741w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea-300x117.png 300w\" sizes=\"(max-width: 741px) 100vw, 741px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90c2f48 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"90c2f48\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" ti-location-arrow\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Fale com Sobel<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-be20fed e-con-full e-flex e-con e-child\" data-id=\"be20fed\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14918c7 elementor-widget elementor-widget-heading\" data-id=\"14918c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">FDA - Solicita\u00e7\u00e3o de Novo - Novos Dispositivos de Classe I\/II<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a53eaa1 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"a53eaa1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b618d20 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"b618d20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Voc\u00ea n\u00e3o tem um predicado? Criamos uma estrat\u00e9gia clara de De Novo, propomos os controles especiais corretos, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-861be12 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"861be12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" For novel, low-to-moderate-risk devices with no suitable predicate, a De Novo request can create a new Class I\/II classification\u2014if your benefit\u2013risk story and proposed controls are clear. We provide a consulting and documentation service that defines your De Novo strategy, proposes special controls, organizes clinical and nonclinical evidence, and packages everything in FDA\u2019s eSTAR template. From October 1, 2025, De Novo submissions must use eSTAR unless exempted.\"}]\" data-inline-monday=\"true\"><strong>No caso de dispositivos novos, de risco baixo a moderado, sem um predicado adequado, uma solicita\u00e7\u00e3o de De Novo pode criar uma nova classifica\u00e7\u00e3o de Classe I\/II - se a sua hist\u00f3ria de risco-benef\u00edcio e os controles propostos forem claros. Fornecemos um servi\u00e7o de consultoria e documenta\u00e7\u00e3o que define a sua estrat\u00e9gia De Novo, prop\u00f5e controles especiais, organiza evid\u00eancias cl\u00ednicas e n\u00e3o cl\u00ednicas e empacota tudo no modelo eSTAR da FDA. A partir de 1\u00ba de outubro de 2025, os envios De Novo dever\u00e3o usar o eSTAR, a menos que voc\u00ea esteja isento.  <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0fae6a7 e-con-full e-flex e-con e-child\" data-id=\"0fae6a7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-929d703 e-con-full e-flex e-con e-child\" data-id=\"929d703\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-049ef93 elementor-widget elementor-widget-text-editor\" data-id=\"049ef93\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Caminho adequado \u00e0 finalidade<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-80d38e2 e-con-full e-flex e-con e-child\" data-id=\"80d38e2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1790a32 elementor-widget elementor-widget-text-editor\" data-id=\"1790a32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Clareza entre benef\u00edcio e risco<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3046834 e-con-full e-flex e-con e-child\" data-id=\"3046834\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ecae339 elementor-widget elementor-widget-text-editor\" data-id=\"ecae339\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Controles especiais transparentes<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a5be18f e-con-full e-flex e-con e-child\" data-id=\"a5be18f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bcb03be elementor-widget elementor-widget-text-editor\" data-id=\"bcb03be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Estrutura compat\u00edvel com o eSTAR<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6024f6f elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"6024f6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Planejar minha estrat\u00e9gia De Novo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c944022 elementor-widget elementor-widget-spacer\" data-id=\"c944022\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b0901e e-con-full e-transform e-flex e-con e-parent\" data-id=\"4b0901e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-48,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1460cc5 elementor-widget elementor-widget-image-carousel\" data-id=\"1460cc5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;7&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay_speed&quot;:3000,&quot;speed&quot;:1500,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;slides_to_show_mobile&quot;:&quot;2&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client2-Sobel-r055w2cgedt2i71p0r1xeqnh0whcf5ht807j9pns4g.jpg\" alt=\"CMOS DRAKE logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client3-Sobel-r055w3aal7uctt0bv9gjz8exmacpmuljk4v0qzmdy8.jpg\" alt=\"Baruel Logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client4-Sobel-r055w484s1vn5eyyprv6jq6e7o82ujp9w9ii89kzs0.jpg\" alt=\"Generate logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client5-Sobel-r055w484s1vn5eyyprv6jq6e7o82ujp9w9ii89kzs0.jpg\" alt=\"Ortosintese logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client6-Sobel-r055w55yyvwxh0xlka9t47xut23g28t08e5zpjjlls.jpg\" alt=\"ZSI logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client7-Sobel-r055w63t5py7smw8esofoppbefyt9xwqkith6ti7fk.jpg\" alt=\"Medtronic logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client8-Sobel-r055w63t5py7smw8esofoppbefyt9xwqkith6ti7fk.jpg\" alt=\"Braun logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client9-Sobel-r055w71ncjzi48uv9b3297grztu6hn0gwngyo3gt9c.jpg\" alt=\"Hypera Pharma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client10-Sobel-r055w7zhje0sfuti3thotp88l7pjpc478s4g5dff34.jpg\" alt=\"M Vision logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client1-Sobel-r055w2cgedt2i71p0r1xeqnh0whcf5ht807j9pns4g.jpg\" alt=\"Andratec logo\" \/><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4102339 e-flex e-con-boxed e-con e-parent\" data-id=\"4102339\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4af96d2 e-con-full e-flex e-con e-child\" data-id=\"4af96d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-caaaa98 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"caaaa98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Por que a De Novo e a eSTAR s\u00e3o importantes agora?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39cf337 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"39cf337\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Choosing the right U.S. pathway and structuring the file correctly are critical for novel devices without a predicate.\"}]\" data-inline-monday=\"true\"><strong>A escolha do caminho certo para os EUA e a estrutura\u00e7\u00e3o correta do arquivo s\u00e3o essenciais para novos dispositivos sem um predicado.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-491f537 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"491f537\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Fale com um especialista<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-31de6a8 e-con-full e-flex e-con e-child\" data-id=\"31de6a8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d4fac8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"3d4fac8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Caminho certo para dispositivos novos:<\/strong> O De Novo cria uma nova classifica\u00e7\u00e3o de Classe I ou II quando n\u00e3o h\u00e1 nenhum predicado e os controles gerais e\/ou especiais podem fornecer uma garantia razo\u00e1vel de seguran\u00e7a e efic\u00e1cia.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>O eSTAR \u00e9 obrigat\u00f3rio para a De Novo:<\/strong> A partir de 1\u00ba de outubro de 2025, as solicita\u00e7\u00f5es da De Novo devem usar o modelo eletr\u00f4nico eSTAR da FDA, a menos que sejam especificamente isentas. Estruturar o conte\u00fado para corresponder ao eSTAR desde o in\u00edcio melhora o recebimento e o encaminhamento. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Aplica-se a revis\u00e3o de aceita\u00e7\u00e3o:<\/strong> A FDA usa uma Lista de Verifica\u00e7\u00e3o de Aceita\u00e7\u00e3o (estilo RTA) para decidir se um arquivo De Novo est\u00e1 administrativamente completo. Os envios incompletos podem ser recusados antes da an\u00e1lise substantiva. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Clareza entre benef\u00edcio e risco:<\/strong> As decis\u00f5es De Novo avaliam benef\u00edcios, riscos e mitiga\u00e7\u00f5es. Sua narrativa deve vincular os riscos aos controles e mostrar como as evid\u00eancias apoiam a classifica\u00e7\u00e3o proposta e os controles especiais. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e1190b2 e-flex e-con-boxed e-con e-parent\" data-id=\"e1190b2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4a22ac1 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4a22ac1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">N\u00f3s nos concentramos nos tr\u00eas grandes riscos - rota errada, hist\u00f3ria fraca do SE e problemas de RTA - e os abordamos em um \u00fanico pacote pronto para o eSTAR.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-000a0d2 animated-slow e-con-full e-flex elementor-invisible e-con e-parent\" data-id=\"000a0d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ff52fa4 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"ff52fa4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quando esse servi\u00e7o de novo \u00e9 adequado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b7341a9 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"b7341a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" We support teams who need a structured, defensible De Novo route\u2014not just a formatted template.\"}]\" data-inline-monday=\"true\">Apoiamos equipes que precisam de uma rota De Novo estruturada e defens\u00e1vel, n\u00e3o apenas de um modelo formatado.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69e0c84 e-flex e-con-boxed e-con e-child\" data-id=\"69e0c84\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-846d12b e-con-full e-flex e-con e-child\" data-id=\"846d12b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-36dd69b elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"36dd69b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">N\u00e3o existe um predicado adequado e o caminho 510(k) n\u00e3o \u00e9 apropriado.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea deseja evitar um PMA demonstrando que os riscos podem ser controlados com controles gerais e especiais.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea precisa definir e justificar controles especiais para um novo tipo de dispositivo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Este \u00e9 o seu primeiro De Novo ou a primeira vez que voc\u00ea usa a eSTAR para um envio De Novo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea tem evid\u00eancias, mas elas est\u00e3o fragmentadas entre as equipes de engenharia, cl\u00ednicas e de risco e precisam de uma \u00fanica hist\u00f3ria de risco-benef\u00edcio.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-02231d5 e-flex e-con-boxed e-con e-parent\" data-id=\"02231d5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b4561e6 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"b4561e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">O que voc\u00ea receber\u00e1<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6d922a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e6d922a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Deliverables are designed around four core outcomes: a clear strategy, transparent controls, mapped evidence, and an eSTAR-ready file.\"}]\" data-inline-monday=\"true\">Os entreg\u00e1veis s\u00e3o projetados em torno de quatro resultados principais: uma estrat\u00e9gia clara, controles transparentes, evid\u00eancias mapeadas e um arquivo pronto para o eSTAR.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5218660 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"5218660\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Fale com um especialista<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d3e5748 e-flex e-con-boxed e-con e-parent\" data-id=\"d3e5748\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5c22f96 e-con-full e-flex e-con e-child\" data-id=\"5c22f96\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ccbbb88 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"ccbbb88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Memorando de Estrat\u00e9gia De Novo<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-918dae0 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"918dae0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Uso pretendido e indica\u00e7\u00f5es de uso, expressos em linguagem apropriada para a De Novo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Justificativa de elegibilidade: por que o De Novo \u00e9 apropriado em compara\u00e7\u00e3o com o 510(k) e o PMA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Resumo inicial de risco e benef\u00edcio: popula\u00e7\u00e3o-alvo, principais benef\u00edcios, principais riscos e justificativa geral.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Recomenda\u00e7\u00e3o para o caminho De Novo, incluindo se voc\u00ea deve buscar alinhamento antecipado por meio de um Q-Submission.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5228561 e-con-full e-flex e-con e-child\" data-id=\"5228561\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc4e2c3 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"dc4e2c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Registro de riscos e mitiga\u00e7\u00f5es com controles especiais propostos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-83b6ea1 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"83b6ea1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Lista estruturada de riscos e modos de falha do dispositivo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Mapeamento de cada risco para controles gerais e controles especiais propostos (por exemplo, testes de desempenho, declara\u00e7\u00f5es de rotulagem, atividades p\u00f3s-comercializa\u00e7\u00e3o).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Justificativa de como cada controle contribui para a seguran\u00e7a e a efic\u00e1cia.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Uma vis\u00e3o que pode ser reutilizada na documenta\u00e7\u00e3o de gerenciamento de riscos e nas discuss\u00f5es com a FDA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7224e85 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"7224e85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt2\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Uso pretendido e indica\u00e7\u00f5es.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt2\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Caracter\u00edsticas tecnol\u00f3gicas (design, materiais, fonte de energia, recursos principais).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt2\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Caracter\u00edsticas de desempenho, quando relevante.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c5ccd46 e-con-full e-flex e-con e-child\" data-id=\"c5ccd46\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6dd0efb elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"6dd0efb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Mapa de evid\u00eancias + registro de lacunas<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9fce6e elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"d9fce6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Mapa de evid\u00eancias n\u00e3o cl\u00ednicas e cl\u00ednicas em rela\u00e7\u00e3o a riscos, pontos finais, alega\u00e7\u00f5es e controles especiais propostos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identifica\u00e7\u00e3o de lacunas ou aspectos com suporte fraco, al\u00e9m de a\u00e7\u00f5es sugeridas (an\u00e1lises adicionais, esclarecimentos ou estudos, quando apropriado).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Links entre protocolos, relat\u00f3rios e tabelas\/figuras importantes para facilitar a navega\u00e7\u00e3o do revisor.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-290e133 e-con-full e-flex e-con e-child\" data-id=\"290e133\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f5f8ac0 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"f5f8ac0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pacote eSTAR e prontid\u00e3o de aceita\u00e7\u00e3o<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9925b88 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"9925b88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Elabora\u00e7\u00e3o de narrativas, resumos e tabelas colocados na estrutura esperada pelo modelo eSTAR da FDA para o De Novo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pr\u00e9-verifica\u00e7\u00e3o da aceita\u00e7\u00e3o interna em rela\u00e7\u00e3o \u00e0 Lista de Verifica\u00e7\u00e3o de Aceita\u00e7\u00e3o De Novo da FDA para reduzir o risco de recusa de aceita\u00e7\u00e3o.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Instru\u00e7\u00f5es claras para seu propriet\u00e1rio regulador\/agente dos EUA sobre como o arquivo eSTAR \u00e9 organizado e onde os principais itens est\u00e3o localizados.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ed4750f e-flex e-con-boxed e-con e-parent\" data-id=\"ed4750f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-703d112 e-con-full e-flex e-con e-child\" data-id=\"703d112\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e11418f e-con-full e-flex e-con e-child\" data-id=\"e11418f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f40406c elementor-widget elementor-widget-heading\" data-id=\"f40406c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Como funciona nosso servi\u00e7o De Novo<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d161658 elementor-widget elementor-widget-text-editor\" data-id=\"d161658\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" We move from basic eligibility and evidence inventory to an eSTAR-ready, acceptance-aware De Novo package.\"}]\" data-inline-monday=\"true\">Passamos da elegibilidade b\u00e1sica e do invent\u00e1rio de evid\u00eancias para um pacote De Novo pronto para o eSTAR e com reconhecimento de aceita\u00e7\u00e3o.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bcd1ad elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"4bcd1ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Planejar minha estrat\u00e9gia De Novo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1fe9cf0 e-con-full e-flex e-con e-child\" data-id=\"1fe9cf0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1920b elementor-widget elementor-widget-image\" data-id=\"0f1920b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1440\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg\" class=\"attachment-full size-full wp-image-15534\" alt=\"A healthcare professional&#039;s office. A laptop displays test results.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg 2560w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-300x169.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1024x576.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-768x432.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1536x864.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-2048x1152.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2773106 e-con-full e-flex e-con e-child\" data-id=\"2773106\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-842c575 e-con-full e-flex e-con e-child\" data-id=\"842c575\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a184760 elementor-widget elementor-widget-heading\" data-id=\"a184760\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">01<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dce863 elementor-widget elementor-widget-heading\" data-id=\"3dce863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Descoberta<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c947c2 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"8c947c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Confirmar o uso pretendido, as indica\u00e7\u00f5es, a descri\u00e7\u00e3o da tecnologia e as evid\u00eancias dispon\u00edveis. Esclare\u00e7a o perfil de risco, os padr\u00f5es atuais e os cronogramas desejados. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0be67d7 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0be67d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2e7a2b5 e-con-full e-flex e-con e-child\" data-id=\"2e7a2b5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-90ddcf6 elementor-widget elementor-widget-heading\" data-id=\"90ddcf6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">02<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a3c734 elementor-widget elementor-widget-heading\" data-id=\"1a3c734\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Elegibilidade e caminho<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b7b21c elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6b7b21c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Analisamos por que o De Novo \u00e9 apropriado em compara\u00e7\u00e3o com o 510(k) ou o PMA, e delineamos uma vis\u00e3o inicial de risco-benef\u00edcio e um conceito para controles especiais. Se for \u00fatil, identificaremos os t\u00f3picos a serem levados \u00e0 FDA em uma Q-Submiss\u00e3o. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51a0d24 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"51a0d24\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7deeea8 e-con-full e-flex e-con e-child\" data-id=\"7deeea8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-05aff25 elementor-widget elementor-widget-heading\" data-id=\"05aff25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">03<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1d1bd7 elementor-widget elementor-widget-heading\" data-id=\"c1d1bd7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Evid\u00eancias e controles<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e13fd44 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"e13fd44\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Crie um registro de risco \u2192 mitiga\u00e7\u00e3o, vincule cada risco a controles especiais gerais e propostos e resuma os dados n\u00e3o cl\u00ednicos e cl\u00ednicos que d\u00e3o suporte a esses controles. Produza um mapa de evid\u00eancias e um registro de lacunas com a\u00e7\u00f5es concretas de acompanhamento. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70263ea elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"70263ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a93dfc3 e-con-full e-flex e-con e-child\" data-id=\"a93dfc3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-629b017 elementor-widget elementor-widget-heading\" data-id=\"629b017\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">04<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf10f20 elementor-widget elementor-widget-heading\" data-id=\"cf10f20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Documenta\u00e7\u00e3o e montagem do eSTAR<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-115a7b7 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"115a7b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Elaborar a narrativa, os resumos e as tabelas principais do De Novo; reuni-los no modelo eSTAR da FDA; e executar uma pr\u00e9-verifica\u00e7\u00e3o no estilo de aceita\u00e7\u00e3o. Entregue um pacote pronto para o eSTAR que seu propriet\u00e1rio regulador possa enviar. <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4444093 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4444093\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ac495c3 animated-slow e-con-full e-flex elementor-invisible e-con e-parent\" data-id=\"ac495c3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-285481a elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"285481a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Escopo e limites<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-82fc140 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"82fc140\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" We keep the scope focused on strategy, evidence organization, and documentation\u2014no hidden promises.\"}]\" data-inline-monday=\"true\">Mantemos o escopo focado em estrat\u00e9gia, organiza\u00e7\u00e3o de evid\u00eancias e documenta\u00e7\u00e3o - sem promessas ocultas.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f4c5b2b e-flex e-con-boxed e-con e-child\" data-id=\"f4c5b2b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7799760 e-con-full e-flex e-con e-child\" data-id=\"7799760\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1870f13 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1870f13\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>No escopo<\/strong><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Estrat\u00e9gia para escolher a De Novo em rela\u00e7\u00e3o a outras vias dos EUA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Desenvolvimento de uma narrativa de benef\u00edcio-risco De Novo e controles especiais propostos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Registro de mitiga\u00e7\u00e3o de riscos e mapeamento de evid\u00eancias para riscos, reivindica\u00e7\u00f5es e controles.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Elabora\u00e7\u00e3o e estrutura\u00e7\u00e3o de conte\u00fado para a solicita\u00e7\u00e3o De Novo no formato eSTAR.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Verifica\u00e7\u00f5es internas de estilo de aceita\u00e7\u00e3o e orienta\u00e7\u00e3o para embalagem de envio.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8a29115 e-con-full e-flex e-con e-child\" data-id=\"8a29115\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6367275 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6367275\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Fora do escopo<\/strong><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Testes laboratoriais ou execu\u00e7\u00e3o de estudos cl\u00ednicos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Cria\u00e7\u00e3o de sua rotulagem oficial (podemos revisar os rascunhos apenas para alinhamento).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Atuar como seu propriet\u00e1rio regulador ou agente nos EUA e enviar diretamente \u00e0 FDA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fornecer consultoria jur\u00eddica ou representar voc\u00ea em a\u00e7\u00f5es de execu\u00e7\u00e3o.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d777947 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d777947\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Consulting and documentation only. We do not perform laboratory testing and do not author labels; clients contract labs and submit via their regulatory owner or U.S. Agent.\"}]\" data-inline-monday=\"true\"><strong>Somente consultoria e documenta\u00e7\u00e3o. N\u00e3o realizamos testes laboratoriais e n\u00e3o criamos r\u00f3tulos; os clientes contratam laborat\u00f3rios e os enviam por meio de seu propriet\u00e1rio regulador ou agente nos EUA. <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-73213f6 e-con-full e-flex e-con e-child\" data-id=\"73213f6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e39690 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"3e39690\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Insumos que solicitaremos de voc\u00ea<\/strong><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Uso pretendido e indica\u00e7\u00f5es de uso (vers\u00e3o preliminar ou de trabalho).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Descri\u00e7\u00e3o da tecnologia do dispositivo e vis\u00e3o geral de alto n\u00edvel da fabrica\u00e7\u00e3o.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Arquivos atuais de gerenciamento de riscos e padr\u00f5es aplic\u00e1veis.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Protocolos e relat\u00f3rios n\u00e3o cl\u00ednicos e cl\u00ednicos; planos e resultados de estat\u00edsticas dispon\u00edveis.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Quaisquer intera\u00e7\u00f5es anteriores com a FDA (por exemplo, tentativas de 510(k), Q-Subs) relevantes para o dispositivo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Rascunho de rotulagem e instru\u00e7\u00f5es de uso (para alinhamento, n\u00e3o para autoria).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Data prevista para a apresenta\u00e7\u00e3o do De Novo e marcos internos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3abd046 e-flex e-con-boxed e-con e-parent\" data-id=\"3abd046\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c442491 elementor-widget elementor-widget-heading\" data-id=\"c442491\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">PERGUNTAS FREQUENTES<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d94f324 elementor-widget elementor-widget-toggle\" data-id=\"d94f324\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2271\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2271\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Quando uma solicita\u00e7\u00e3o De Novo \u00e9 apropriada em vez de uma 510(k)?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2271\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2271\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"De Novo is appropriate when there is no legally marketed predicate device and the device\u2019s risk can be adequately controlled using general controls and, where needed, special controls. If a suitable predicate exists, a 510(k) is usually the primary route.\"}]\" data-inline-monday=\"true\">O De Novo \u00e9 apropriado quando n\u00e3o h\u00e1 um dispositivo predicado comercializado legalmente e o risco do dispositivo pode ser controlado adequadamente usando controles gerais e, quando necess\u00e1rio, controles especiais. Se houver um dispositivo predicado adequado, um 510(k) geralmente \u00e9 o caminho principal. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2272\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2272\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">A eSTAR \u00e9 obrigat\u00f3ria para envios de De Novo?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2272\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2272\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Yes. For De Novo requests submitted on or after October 1, 2025, FDA requires use of the eSTAR template, unless a specific exemption applies.\"}]\" data-inline-monday=\"true\">Sim. Para solicita\u00e7\u00f5es De Novo enviadas em ou ap\u00f3s 1\u00ba de outubro de 2025, a FDA exige o uso do modelo eSTAR, a menos que uma isen\u00e7\u00e3o espec\u00edfica se aplique. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2273\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2273\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Voc\u00ea precisa de dados cl\u00ednicos para um De Novo?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2273\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2273\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"It depends on the device\u2019s risks and claims. Evidence must be sufficient to support the benefit\u2013risk profile and the proposed special controls. For some devices, nonclinical evidence may be enough; others require clinical data.\"}]\" data-inline-monday=\"true\">Depende dos riscos e das alega\u00e7\u00f5es do dispositivo. As evid\u00eancias devem ser suficientes para apoiar o perfil de risco-benef\u00edcio e os controles especiais propostos. Para alguns dispositivos, a evid\u00eancia n\u00e3o cl\u00ednica pode ser suficiente; outros exigem dados cl\u00ednicos.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2274\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2274\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Voc\u00ea pode enviar a solicita\u00e7\u00e3o De Novo para a FDA em nosso nome?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2274\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2274\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"No. The formal submission is made by your regulatory owner or U.S. Agent. We prepare the strategy, narrative, and eSTAR content so their submission is organized and ready for FDA intake.\"}]\" data-inline-monday=\"true\">N\u00e3o. O envio formal \u00e9 feito pelo seu propriet\u00e1rio regulador ou agente nos EUA. Preparamos a estrat\u00e9gia, a narrativa e o conte\u00fado do eSTAR para que o envio seja organizado e esteja pronto para ser recebido pela FDA.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2275\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2275\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Esse servi\u00e7o pode nos ajudar a nos preparar para um Q-Submission?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2275\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2275\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Yes. As part of the strategy phase, we can identify key questions and draft materials you may want to bring to FDA in a Q-Submission to de-risk your De Novo before filing.\"}]\" data-inline-monday=\"true\">Sim. Como parte da fase de estrat\u00e9gia, podemos identificar as principais perguntas e redigir materiais que voc\u00ea pode querer levar \u00e0 FDA em uma Q-Submission para reduzir o risco do seu De Novo antes do registro. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9258540 e-flex e-con-boxed e-con e-parent\" data-id=\"9258540\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4a48ff2 e-con-full e-flex e-con e-child\" data-id=\"4a48ff2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45293f3 elementor-widget elementor-widget-image\" data-id=\"45293f3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"2560\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg\" class=\"attachment-full size-full wp-image-15583\" alt=\"A woman holding a smartphone in one hand and a stethoscope in the other. She wears medical gloves and appears to be in a hospital setting. Regulatory Medical Device Consultancy.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg 1920w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-225x300.jpg 225w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-768x1024.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1152x1536.jpg 1152w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1536x2048.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1f4f382 e-con-full e-flex e-con e-child\" data-id=\"1f4f382\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-db29410 elementor-widget elementor-widget-heading\" data-id=\"db29410\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Crie uma solicita\u00e7\u00e3o de novo com estrat\u00e9gia clara, evid\u00eancia e estrutura eSTAR<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb092e7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"fb092e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" If your device has no predicate and you want a fit-for-purpose pathway instead of PMA, a De Novo request can create the right classification\u2014if risks, controls, and evidence are presented clearly. We help you define the De Novo strategy, propose special controls, map evidence to risk, and assemble an eSTAR-compliant file that anticipates acceptance checks and supports a faster, clearer review.\"}]\" data-inline-monday=\"true\">Se o seu dispositivo n\u00e3o tem predicado e voc\u00ea deseja um caminho adequado \u00e0 finalidade em vez de PMA, uma solicita\u00e7\u00e3o De Novo pode criar a classifica\u00e7\u00e3o certa - se os riscos, controles e evid\u00eancias forem apresentados com clareza. Ajudamos voc\u00ea a definir a estrat\u00e9gia De Novo, propor controles especiais, mapear as evid\u00eancias para os riscos e montar um arquivo em conformidade com o eSTAR que antecipe as verifica\u00e7\u00f5es de aceita\u00e7\u00e3o e ofere\u00e7a suporte a uma an\u00e1lise mais r\u00e1pida e clara. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03ee904 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"03ee904\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Planejar minha estrat\u00e9gia De Novo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-14cdf9d e-flex e-con-boxed e-con e-parent\" data-id=\"14cdf9d\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8ebbd3a e-con-full e-flex e-con e-child\" data-id=\"8ebbd3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0a085d2 elementor-align-center elementor-widget elementor-widget-lottie\" data-id=\"0a085d2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;source_json&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/Contact-us.json&quot;,&quot;id&quot;:16710,&quot;size&quot;:&quot;&quot;,&quot;alt&quot;:&quot;&quot;,&quot;source&quot;:&quot;library&quot;},&quot;loop&quot;:&quot;yes&quot;,&quot;source&quot;:&quot;media_file&quot;,&quot;caption_source&quot;:&quot;none&quot;,&quot;link_to&quot;:&quot;none&quot;,&quot;trigger&quot;:&quot;arriving_to_viewport&quot;,&quot;viewport&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;play_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;start_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;end_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:100,&quot;sizes&quot;:[]},&quot;renderer&quot;:&quot;svg&quot;}\" data-widget_type=\"lottie.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"e-lottie__container\"><div class=\"e-lottie__animation\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-055d570 e-con-full e-flex e-con e-child\" data-id=\"055d570\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6ad324c elementor-widget elementor-widget-heading\" data-id=\"6ad324c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Entre em contato<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c92c174 elementor-widget elementor-widget-heading\" data-id=\"c92c174\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Gostar\u00edamos muito de falar com voc\u00ea.<br>Fique \u00e0 vontade para entrar em contato usando os detalhes abaixo.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8957085 elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"8957085\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Pr\\u00f3ximo&quot;,&quot;step_previous_label&quot;:&quot;Anterior&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_lp_us_denovo_eng\" name=\"Formul\u00e1rio de contato - us_denovo_eng\" aria-label=\"Formul\u00e1rio de contato - us_denovo_eng\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"21989\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"8957085\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNome completo\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqui\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEndere\u00e7o de e-mail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqui\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tN\u00famero de telefone\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqui\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Apenas n\u00fameros e caracteres de telefone (#, -, *, etc.) s\u00e3o aceitos.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEmpresa\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqui\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMensagem\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Digite aqui\" required=\"required\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">&nbsp;&nbsp;  Concordo com a declara\u00e7\u00e3o de privacidade de dados e com os termos e condi\u00e7\u00f5es publicados neste site<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-newslettercheck elementor-col-100\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[newslettercheck]\" id=\"form-field-newslettercheck\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\">\n\t\t\t\t<label for=\"form-field-newslettercheck\">&nbsp; &nbsp;Concordo em receber boletins informativos quinzenais com atualiza\u00e7\u00f5es sobre o mercado regulat\u00f3rio global.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_source elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_source]\" id=\"form-field-utm_source\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_campaign elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_campaign]\" id=\"form-field-utm_campaign\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_adgroupname elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_adgroupname]\" id=\"form-field-utm_adgroupname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_term elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_term]\" id=\"form-field-utm_term\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-gclid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[gclid]\" id=\"form-field-gclid\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_content elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_content]\" id=\"form-field-utm_content\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_device elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_device]\" id=\"form-field-utm_device\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\" id=\"btn_us_denovo_eng\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Enviar<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e77e6b elementor-widget elementor-widget-html\" data-id=\"1e77e6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<link data-minify=\"1\" rel=\"stylesheet\" href=\"https:\/\/ciparoni.com\/wp-content\/cache\/background-css\/1\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css?ver=1760368402&amp;wpr_t=1760357602\">\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js?ver=1760368402\"><\/script>\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/jquery\/3.7.1\/jquery.min.js?ver=1760368402\"><\/script>\r\n\r\n<script>\r\n    const phoneInputField = document.querySelectorAll('input[type=\"tel\"]');\r\n    const btForm = document.querySelectorAll('.elementor-button[type=\"submit\"]');\r\n    let telefones = [];\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var phone_number = window.intlTelInput(phoneInputField[i], {\r\n        separateDialCode: true,\r\n        preferredCountries:[\"br\",\"us\", \"de\", \"fr\" ],\r\n        hiddenInput: \"full\",\r\n        utilsScript: \"\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n        });\r\n\r\n        telefones[i] = phone_number;\r\n    }\r\n    $(phoneInputField).each(function(i) {\r\n        $(\"form\").submit(function() {\r\n            var full_number = telefones[i].getNumber(intlTelInputUtils.numberFormat.E164);\r\n            $(phoneInputField[i]).val(full_number);\r\n            console.log(phoneInputField[i]);\r\n            console.log(phone_number);\r\n        });\r\n    });\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var larguraInput = phoneInputField[i].getBoundingClientRect().width;\r\n        $(\".iti__country-list\").css({width: larguraInput});\r\n    }\r\n\r\n    window.addEventListener(\"resize\", function() {\r\n      for (let i = 0; i < phoneInputField.length; i++) {\r\n        const larguraInput = phoneInputField[i].offsetWidth;\r\n        $(\".iti__country-list\").css({ width: larguraInput });\r\n      }\r\n  });\r\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-db4ddb0 e-flex e-con-boxed e-con e-parent\" data-id=\"db4ddb0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a841c2 elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"8a841c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-site-logo.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\" class=\"attachment-full size-full wp-image-4522\" alt=\"Logo Sobel White\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png 741w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White-300x117.png 300w\" sizes=\"(max-width: 741px) 100vw, 741px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81dfcfa elementor-widget elementor-widget-heading\" data-id=\"81dfcfa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/declaracao-de-privacidade-dos-eua\/\" target=\"_blank\">Pol\u00edtica de privacidade<\/a><\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fale com Sobel FDA - Solicita\u00e7\u00e3o de Novo - Novos Dispositivos de Classe I\/II Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR Voc\u00ea n\u00e3o tem um predicado? Criamos uma estrat\u00e9gia clara de De Novo, propomos os controles especiais corretos, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":15867,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-21989","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR<\/title>\n<meta name=\"description\" content=\"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR\" \/>\n<meta property=\"og:description\" content=\"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-09T20:11:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png\" \/>\n\t<meta property=\"og:image:width\" content=\"741\" \/>\n\t<meta property=\"og:image:height\" content=\"290\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/\",\"name\":\"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-BlueSea.png\",\"datePublished\":\"2025-11-27T22:54:35+00:00\",\"dateModified\":\"2026-02-09T20:11:06+00:00\",\"description\":\"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/#breadcrumb\"},\"inLanguage\":\"pt-BR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-BR\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/#primaryimage\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-BlueSea.png\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-BlueSea.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/us-denovo\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Materiais\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/materiais\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Solicita\u00e7\u00e3o De Novo dos EUA &#8211; Estrat\u00e9gia, Evid\u00eancia e eSTAR\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#website\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"pt-BR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-BR\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR","description":"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/","og_locale":"pt_BR","og_type":"article","og_title":"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR","og_description":"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.","og_url":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/","og_site_name":"Sobel","article_modified_time":"2026-02-09T20:11:06+00:00","og_image":[{"width":741,"height":290,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. tempo de leitura":"9 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/","url":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/","name":"Solicita\u00e7\u00e3o De Novo dos EUA - Estrat\u00e9gia, Evid\u00eancia e eSTAR","isPartOf":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png","datePublished":"2025-11-27T22:54:35+00:00","dateModified":"2026-02-09T20:11:06+00:00","description":"Voc\u00ea n\u00e3o tem predicados? Criamos uma estrat\u00e9gia De Novo clara, propomos controles especiais, mapeamos as evid\u00eancias para os riscos e empacotamos o seu arquivo no modelo eSTAR da FDA - pronto para a an\u00e1lise de aceita\u00e7\u00e3o e focado em uma hist\u00f3ria de risco-benef\u00edcio defens\u00e1vel.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/#breadcrumb"},"inLanguage":"pt-BR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/"]}]},{"@type":"ImageObject","inLanguage":"pt-BR","@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png"},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/pt-br\/materiais\/us-denovo\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/sobelconsult.com\/pt-br\/home\/"},{"@type":"ListItem","position":2,"name":"Materiais","item":"https:\/\/sobelconsult.com\/pt-br\/materiais\/"},{"@type":"ListItem","position":3,"name":"Solicita\u00e7\u00e3o De Novo dos EUA &#8211; Estrat\u00e9gia, Evid\u00eancia e eSTAR"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/pt-br\/#website","url":"https:\/\/sobelconsult.com\/pt-br\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/pt-br\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"pt-BR"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/pt-br\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/pt-br\/","logo":{"@type":"ImageObject","inLanguage":"pt-BR","@id":"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/21989","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/comments?post=21989"}],"version-history":[{"count":1,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/21989\/revisions"}],"predecessor-version":[{"id":29770,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/21989\/revisions\/29770"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/15867"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/media?parent=21989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}