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).
Recommended Actions
- Identify if your decision falls under “517A decisions” category
- Submit appeal request within 30 days if challenging a significant decision
- Clearly specify if requesting in-person meeting or teleconference
- Request substantive summary through CDRH Document Control Center if needed
- Mark request clearly as “Request for Substantive Summary under 517A”
- Include relevant submission identification number in request
- For non-517A decisions, follow standard 21 CFR 10.75 appeal process within 60 days
- 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:
- 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
This post is licensed under CC BY 4.0 by the author.