FDA Medical Device Regulatory Consulting

Entering the U.S. medical device market requires precision, strategy, and full alignment with FDA expectations. From classification to submission, Sobel supports manufacturers at every stage of the FDA process — transforming complex requirements into a clear, efficient, and compliant pathway to approval.

For who?

With deep experience in FDA processes and global regulatory frameworks, Sobel provides the level of technical and strategic support that companies need to access the U.S. market successfully.

Why do you need this service?

FDA compliance is a legal requirement, and misunderstanding these obligations can lead to project stoppages, rejections, or enforcement actions.

Specialized regulatory guidance helps you prepare submissions and documentation that meet FDA expectations without unnecessary rework or delays.

With expert support, your team strengthens decision-making, reduces regulatory risk, and moves through each FDA step with greater clarity and confidence.

Medical Device Regulatory Consulting for a Confident FDA Submission Process

Our approach blends technical expertise with practical execution, guiding your company through every regulatory decision.

Sobel provides a complete medical device regulatory consulting framework tailored to your device and market goals.

Choose Your Service

Select the FDA regulatory service you need — and if you're unsure, we help you identify the right pathway for your device.

Provide Documentation

Sobel requests all required documents so the regulatory process can move forward efficiently and without delays.

Track Your Project

We execute the work while you follow every step in real time through our online project platform.

Which service applies to your medical device?

FDA regulations require a robust, evidence-based approach to safety, effectiveness, and documentation. You can choose from the following options, depending on your device’s needs and stage of development:

Premarket Notification 510(k)

Recommended for manufacturers who need to demonstrate substantial equivalence to a predicate device. This pathway includes classification support, predicate selection, gap analysis, submission preparation, and responses to FDA review comments.

FURLS Device Registration & Listing

For manufacturers entering the U.S. market or introducing new devices. Sobel manages the registration and listing process in the FURLS database so your products can be legally commercialized in the U.S.

FURLS Facility Registration

Required for foreign establishments manufacturing medical devices for the U.S. market. Sobel creates and registers your facility in the FURLS system, ensuring it complies with FDA establishment registration rules.

FURLS Device & Facility Maintenance (Annual)

Ideal for companies that already sell medical devices in the U.S. and must keep their establishment and device listings active. Ensures ongoing compliance with annual FDA registration obligations.

Section 513(g)

Recommended when manufacturers need official clarity from the FDA regarding device classification or applicable regulatory requirements. Sobel prepares and submits the 513(g) request, helping you define the correct regulatory pathway early on.

MDUFA Small Business Certification

Essential for companies seeking reduced FDA user fees. Sobel prepares and submits the documentation required for certification, helping qualified manufacturers significantly decrease FDA submission costs.

GUDID (UDI Registration)

Required for devices subject to FDA UDI rules. Sobel creates your GUDID account and enters all UDI and label information so your device is properly registered in the FDA database.

Label Evaluation

Recommended for manufacturers preparing labels for the U.S. market. Sobel verifies compliance, identifies gaps, and provides actionable guidance to correct or update your labeling according to FDA requirements.

Regulatory Affairs Support (Monthly Consultancy)

Designed for companies that need ongoing support with FDA-related questions. Provides fast, written regulatory guidance for day-to-day decisions, so your team remains aligned with FDA expectations.

Not sure how to register your medical device product with Anvisa?

Our medical device regulatory consulting approach bridges knowledge gaps, reduces risk, and accelerates your time-to-market.

Related
Services

With Sobel, you eliminate uncertainty and prevent common mistakes that compromise timelines and budgets. You can also have support on these complementary services:

Clinical Evaluation (CEP, CER)

Support for CEP and CER development, including strategic planning, literature reviews and more.

US Agent Service

Navigate market access in the U.S.A. with Sobel as your device US Agent.

Regulatory and ISO 14971 training

Expert-led training programs that strengthen risk management and compliance.

Ready to accelerate your FDA compliance?

Sobel provides a comprehensive, strategic, and practical approach to medical device regulatory consulting, giving your company the clarity, confidence, and regulatory readiness needed to enter and succeed in the U.S. market.

Contact us to start your FDA compliance pathway with confidence.

Still have questions? Checkout our FAQ

1. What is the first regulatory step when entering the U.S. medical device market?

Most companies begin by determining their device classification (Class I, II, or III) and identifying the applicable regulatory pathway, such as 510(k), De Novo, PMA, or exemption. This step defines what documentation, testing, and registration activities will be required.

2. How do I know whether my device needs a 510(k), De Novo, or PMA submission?

The correct pathway depends on your device’s intended use, level of risk, and the existence of a predicate device on the U.S. market. Classification analysis and predicate identification are essential early steps, and Sobel supports you in evaluating all available options.

3. Do I need to register my company with the FDA before selling a device?

Yes. All manufacturers, including foreign companies, must complete Facility Registration and Device Listing through the FURLS system. These registrations must also be renewed annually.

4. What is UDI and do I need a GUDID registration?

Most devices sold in the U.S. must have a Unique Device Identifier (UDI), and the information must be entered into the FDA’s GUDID database. Sobel creates your account and records all required device data, but the UDI itself must be provided by the manufacturer.

5. Can Sobel help determine which documents are missing for FDA compliance?

Yes. Sobel performs detailed regulatory gap assessments to identify missing tests, incomplete sections, or documentation that does not meet FDA requirements. This prevents rework and accelerates the review process.

6. What happens if the FDA issues review comments or requests additional information?

Sobel supports you in understanding, interpreting, and responding to FDA comments. Clear, well-structured responses are essential to avoid prolonging the review cycle or triggering additional rounds of questions.

7. Do I qualify for reduced submission fees under the MDUFA Small Business Program?

It depends. Small Business Certification can significantly reduce FDA user fees, but requires specific financial documentation and a formal request to the FDA. Sobel manages the submission and communication process for this certification.