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:
  • Premarket Notification regulation (21CFR Part 807, Subpart E)
  • Investigational Device Exemptions (IDE) regulation (21 CFR 812)
  • Premarket Approval regulation (21 CFR 814)