PMA Application Contents
A PMA application must contain sufficient valid scientific evidence to demonstrate that the device is safe and effective for its intended use. Under 21 CFR § 814.20, required sections include:
Required PMA sections
| Section | Description |
|---|---|
| Table of contents | Organised reference to all sections |
| Summary | Summary of safety and effectiveness data (SSED) — publicly posted after approval |
| Device description | Complete description of all models, components, materials, accessories |
| Indications for use | Detailed statement of intended use and target population |
| Contraindications, warnings, precautions | Known hazards, limitations, precautions |
| Device design | Engineering drawings, specifications, materials |
| Manufacturing information | Manufacturing process, facilities, QMS compliance |
| Non-clinical studies | Bench testing, biocompatibility (ISO 10993), animal studies, in vitro |
| Clinical investigations | Full clinical study report(s) — typically IDE-approved study |
| Risk-benefit analysis | Comprehensive benefit-risk determination |
| Labelling | Final label, IFU, packaging labelling |
| Financial certification/disclosure | Per 21 CFR Part 54 — financial interests of clinical investigators |
| Environmental assessment | Or exclusion claim under 21 CFR § 25.30/25.34 |
| Truthful and accurate statement | Signed certification |
Clinical evidence requirements
PMA clinical data must come from well-controlled investigations that:
- Were conducted under an approved IDE (or are exempt from IDE requirements)
- Were reviewed and approved by an IRB
- Were conducted in accordance with ICH E6 GCP
- Produced data that are valid and statistically meaningful
FDA may also accept post-approval study data from comparable studies or published literature in certain circumstances — discuss with FDA via pre-submission meeting.