US · FDA PMA · Class III Devices
Class III PMA Strategy & Evidence for FDA Submission
Class III PMA: we organize clinical + nonclinical evidence, craft a clear benefit–risk story, and build the submission documentation delivered to FDA—structured for eSTAR (voluntary for certain PMAs) or eCopy—ready for acceptance and filing.
Premarket Approval (PMA) is FDA’s highest bar for medical devices. We provide a consulting and documentation service that brings your Class III evidence together into a clear, 21 CFR-aligned benefit–risk narrative, prepares for acceptance and filing checks, and structures the PMA dossier for eSTAR (voluntary for certain PMAs) or eCopy, ready for submission by your regulatory owner.
21 CFR 814.20–aligned structure
Evidence clarity (clinical + nonclinical)
Filing confidence & panel-ready narrative
Why PMA Strategy & Evidence Organization Matters
For Class III devices, FDA approval is based on valid scientific evidence showing a reasonable assurance of safety and effectiveness for the intended use. That evidence must be organized and presented in a way that matches PMA expectations—not just stacked into a binder.
- PMA = highest bar: Class III devices use the PMA route; approval depends on a complete, coherent evidence package rather than a checklist of forms.
- Acceptance & filing gate the review: FDA first checks administrative completeness (acceptance) and basic technical adequacy (filing). FDA notifies within 45 days whether a PMA is filed; the 180-day review goal runs from filing, not from first contact.
- eSTAR vs. eCopy: eSTAR templates are available (voluntary) for certain PMA submissions and can improve intake quality; otherwise, PMAs are submitted via eCopy through the CDRH Portal.
- Advisory panels: FDA may refer PMAs to an advisory committee for public discussion before a decision—weak or scattered narratives make this stage harder.
When This Service Is the Right Fit
We work with teams who already have or are close to final evidence and need structure, clarity, and PMA-specific framing.
Without a mapped process, companies risk inconsistent labeling, undocumented decisions, and unresolved questions in audits or inspections.
What You Will Receive
Deliverables are built around one outcome: a structured PMA submission package that makes your evidence and decisions clear to FDA reviewers.
PMA Strategy Memo
- Intended use and indications for use, summarized in language suitable for the PMA.
- Regulatory history and rationale for the PMA pathway (including alternatives considered).
- High-level comparison to alternative therapies or devices in the same space.
- Recommended PMA plan, including key sections, sequencing, and use of eSTAR (where eligible) vs. eCopy.
Evidence Summaries (Clinical + Nonclinical)
- Structured nonclinical summaries (bench, software, biocompatibility, sterilization, packaging, human factors, etc.) mapped to PMA content requirements.
- Clinical evidence summaries tied to endpoints and claims, including pivotal/IDE study results and supportive studies.
- Traceability from endpoints and hypotheses to tables, figures, and reports.
- Mapping to applicable standards and relevant 21 CFR 814.20 content items so reviewers see how each requirement is addressed.
Benefit–Risk Narrative
- Clear articulation of expected benefits by indication and patient group.
- Description of known and probable risks, including how they were mitigated and monitored.
- Integrated discussion of valid scientific evidence supporting reasonable assurance of safety and effectiveness.
- Decision-oriented summary that can be reused in responses to questions or potential advisory panel briefing.
Filing-Readiness Checklist
- Acceptance and filing checklist cross-referenced to PMA sections and annexes.
- Confirmation that required modules, forms, and core elements are present and internally consistent.
- Practical notes on common acceptance/filing issues and how they were addressed in your dossier.
Submission Documentation for FDA
- PMA submission documentation arranged in a structure compatible with eSTAR (where applicable) or organized for eCopy formatting and CDRH Portal upload.
- Tables, figures, and section headings assembled in a way that matches FDA’s reading sequence.
- Outline or draft content that can be used to prepare internal and external presentations (e.g., potential panel discussion points).
How Our PMA Service Works
We start from your evidence and timelines and build forward to a structured PMA package.
Discovery
Evidence Mapping
Benefit–Risk Story & Documentationn
Filing Readiness & Packaging for FDA
Scope & Exclusions
We keep roles and responsibilities clear so you know exactly what is covered.
In Scope
- Consulting on PMA strategy and dossier structure.
- Evidence mapping and integrated benefit–risk narrative drafting.
- Preparation of PMA sections, tables, figures, and checklists for acceptance/filing readiness.
- Structuring documentation for eSTAR (where voluntary and applicable) or eCopy packaging.
- Support in outlining advisory panel briefing points from the existing evidence.
Out of Scope
- Laboratory testing or generation of new evidence.
- Acting as your U.S. Agent or Official Correspondent.
- Authoring or owning official labeling; we use labeling drafts for context only.
- Submitting the PMA to FDA or managing official FDA correspondence (done by your regulatory owner/U.S. Agent).
Consulting and documentation only. We do not perform laboratory testing and do not author labels; clients contract labs and manage the official submission and correspondence via their regulatory owner or U.S. Agent.
Inputs We Will Request From You
- Intended use and indications for use (current draft or working assumptions).
- Device / technology description and manufacturing overview.
- Risk management files and major design documents relevant to the PMA.
- Clinical protocols, statistics plans, IDE and pivotal study results, and any key supportive studies.
- Bench and nonclinical reports (performance, biocompatibility, software, usability, etc.).
- Draft labeling and Instructions for Use (for context and alignment, not authorship).
- Target filing date and any anticipated advisory panel concerns.
FREQUENTLY ASKED QUESTIONS
First, FDA performs acceptance and filing checks. FDA aims to notify within 45 days whether the PMA is filed. The 180-day PMA review goal is measured from the filing date, not the initial submission.
No. eSTAR is voluntary for certain PMA submissions. Where eSTAR is available, it can improve structure and intake quality; otherwise, PMAs are submitted as an eCopy via the CDRH Portal.
Approval is based on valid scientific evidence providing reasonable assurance of safety and effectiveness for the intended use(s) of the Class III device.
No. We work from your existing or planned evidence set. Laboratory testing and trial operations remain under your contracts with CROs and labs.
Formal PMA submission and official correspondence are handled by your designated regulatory owner or U.S. Agent. We support them by structuring the dossier and preparing documentation and narratives that can be used in those interactions.
Yes. Within the scope of existing evidence, we help organize key benefit–risk messages, panel-relevant summaries, and document references that can be used in internal rehearsal and external briefing materials.
Organize Your Class III PMA Into a Clear, Review-Ready Story
A Class III PMA is not just a collection of reports—it is a structured argument that your device provides a reasonable assurance of safety and effectiveness. We help you organize clinical and nonclinical evidence, align claims with data, and build the PMA submission documentation for eSTAR or eCopy so your team can approach acceptance, filing, and review with confidence.
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