Post-Market Overview & Ongoing Responsibilities
What post-market obligations apply?
Once a device is on the US market — whether cleared, approved, or exempt — manufacturers, importers, and user facilities have ongoing obligations to FDA. These fall into five main areas:
| Obligation | Regulatory basis | Applies to |
|---|---|---|
| Medical Device Reporting (MDR) | 21 CFR Part 803 | Manufacturers, importers, user facilities |
| Recalls and corrections | 21 CFR Part 806 | Manufacturers and importers |
| Post-market surveillance | 21 CFR § 522 / Part 822 | Manufacturers (when ordered) |
| QMS maintenance | 21 CFR Part 820 (QMSR) | Manufacturers |
| Registration renewal | 21 CFR Part 807 | All registered establishments |
The post-market surveillance ecosystem
FDA uses multiple complementary systems to monitor the safety of marketed devices:
- MAUDE database — publicly searchable MDR database
- MedWatch — voluntary reporting by healthcare professionals and patients
- TPLC (Total Product Life Cycle) database — FDA's internal device tracking system
- NEST (National Evaluation System for health Technology) — real-world evidence network
- 522 PMS studies — mandatory studies ordered by FDA for specific device types
Changes to cleared/approved devices
After clearance or approval, any change that could significantly affect safety or effectiveness requires a new premarket submission:
- For 510(k)-cleared devices: evaluate against the Special 510(k) or Traditional 510(k) threshold
- For PMA-approved devices: evaluate against the PMA supplement threshold
- For De Novo-classified devices: follow the applicable special controls and FDA guidance