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.
What You Need to Know? 👇
What are the key differences between 517A and non-517A appeals under CDRH processes?
517A appeals must be submitted within 30 days with no extensions allowed, while non-517A appeals have a 60-day deadline with possible extensions for good cause. 517A appeals also have specific timeline requirements for meetings and decisions that don’t apply to other appeals.
How long does CDRH have to respond to supervisory review requests?
For 517A decisions with meetings, CDRH must render a decision within 30 days of the meeting or teleconference. Without meetings, decisions must be made within 45 days of the appeal request. Non-517A appeals follow similar timeframes when resources permit.
Can new data be submitted as part of a 21 CFR 10.75 appeal?
Appeals must be based on information already in the administrative file at the time of the original decision. New data will generally result in referral back to the original review level, though review authorities may allow minor clarifications or analyses.
What is the Medical Devices Dispute Resolution Panel and when can it be requested?
The DRP provides independent review of scientific controversies between stakeholders and FDA. It can be requested as part of a Center-level appeal under 21 CFR 10.75, typically after exhausting lower-level review options and when the matter involves primarily scientific disputes.
What happens if I file multiple appeals or petitions simultaneously?
CDRH prefers only one review path be pursued to avoid resource duplication and confusion. The Center will typically contact companies to determine their preferred approach and may decline to consider appeals involving matters under active Commissioner review.
How does the CDRH Ombudsman assist in dispute resolution?
The Ombudsman helps clarify issues, mediate meetings, and facilitate discussions before formal appeals. They also investigate bias or retaliation allegations confidentially and can assist with telescoped review requests when special circumstances warrant direct Center-level review.
What You Need to Do 👇
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 🔗
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