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Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions

This guidance provides CDRH's interpretation of section 517A of the FD&C Act regarding appeals processes, documentation requirements, and timeframes for significant decisions in medical device submissions (510(k), PMA, HDE, IDE, and Breakthrough Device Designation).

  1. Identify if your decision falls under “517A decisions” category
  2. Submit appeal request within 30 days if challenging a significant decision
  3. Clearly specify if requesting in-person meeting or teleconference
  4. Request substantive summary through CDRH Document Control Center if needed
  5. Mark request clearly as “Request for Substantive Summary under 517A”
  6. Include relevant submission identification number in request
  7. For non-517A decisions, follow standard 21 CFR 10.75 appeal process within 60 days
  8. Maintain documentation of all communications and timeframes during appeal process

Key Considerations

Other considerations

  • Significant decisions (“517A decisions”) include:
    • 510(k): Not Substantially Equivalent; Substantially Equivalent
    • PMA/HDE: Not Approvable; Approvable; Approval; Denial
    • Breakthrough Device Designation: Grant; Denial
    • IDE: Disapproval; Approval
  • Timeframes for appeals:
    • Request must be submitted within 30 days of decision
    • FDA must schedule in-person/teleconference review within 30 days of request
    • FDA must issue decision within 45 days of request, or 30 days after meeting
  • Substantive summary must include:
    • Explanation of regulatory decision rationale
    • How least burdensome requirements were applied
    • Documentation of significant controversies/differences of opinion
    • References to literature and standards used

      Relevant Guidances

  • Procedures for Supervisory Review, Appeals, and Dispute Resolution for Medical Device Decisions

Original guidance

  • Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
  • HTML / PDF
  • Issue date: 2020-03-27
  • Last changed date: 2023-05-10
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Administrative / Procedural, Premarket Approval (PMA)
  • ReguVirta summary file ID: 2f6ad4509a7cbd9040f37b3e54a62a9b
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