QS & the FDA: FDA Regulations
Medical device manufacturers must be compliant with several regulations in addition to the FDA Quality System regulation. Links to these regulations are provided below:
- Quality System (QS) regulation (21 CFR Part 820) and Preamble
- General Device Labeling (21 CFR Part 801)
- Medical Device Reporting (MDR) regulation (21 CFR Part 803)
- Corrections and Removals regulation (21 CFR Part 806)
- In Vitro Diagnostic Products regulation (21CR Part 809)
- Medical Device Recall regulation (21CFR Part 810)
- Electronic Records; Electronic Signatures (21 CFR Part 11) and Comments
- Premarket Regulations: