Procedures for Supervisory Review, Appeals, and Dispute Resolution for Medical Device Decisions
This guidance outlines the various processes available to external stakeholders to request additional review of decisions or actions by the Center for Devices and Radiological Health (CDRH). It covers supervisory reviews (appeals), petitions, hearings, and the Medical Devices Dispute Resolution Panel (DRP) processes.
Recommended Actions
- Attempt to resolve disputes through discussion and mediation before formal appeals
- Follow proper appeal hierarchy (Division → Office → OPEQ → Center → Commissioner)
- Submit appeals within required timeframes:
- 30 days for 517A decisions
- 60 days for non-517A decisions
- Ensure appeal packages include:
- Clear marking as “APPEAL”
- Associated document numbers
- Executive summary with clear statement of relief sought
- Reference to existing administrative record
- Consider requesting meetings/teleconferences with review authority
- Avoid parallel review processes (simultaneous appeal and new submission)
- Consult CDRH Ombudsman for guidance on process and bias/retaliation concerns
- Consider alternative dispute resolution mechanisms when appropriate (petitions, hearings, DRP)
- Exhaust administrative remedies before pursuing judicial review
Key Considerations
Other considerations
- Appeals of 517A decisions must be submitted within 30 days of the decision
- Appeals of non-517A decisions must be submitted within 60 days of the decision
- For 517A decisions with requested meetings, decisions must be rendered within 30 days of the meeting
- For 517A decisions without meetings, decisions must be rendered within 45 days of the appeal request
- Appeals should be based on information already in the administrative file at the time of the decision
- New information may result in referral back to original review level
- Parallel review (simultaneous appeal and new submission) is discouraged
- DRP requests must be made within context of Center-level review
- Petitions for reconsideration must be filed within 30 days of Commissioner decision
Relevant Guidances
- Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
Related references and norms
- 21 CFR Part 10: Administrative Practices and Procedures
- 21 CFR Part 12: Formal Evidentiary Public Hearing
- 21 CFR Part 13: Public Hearing Before a Board of Inquiry
- 21 CFR Part 14: Public Hearing Before a Public Advisory Committee
- 21 CFR Part 15: Public Hearing Before the Commissioner
- 21 CFR Part 16: Regulatory Hearing Before the FDA
- 21 CFR 800.75: Requests for Supervisory Review of Certain Decisions Made by CDRH
Original guidance
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