Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions

What You Need to Know? 👇

What is considered a “significant decision” under Section 517A?

Significant decisions include final determinations on 510(k) submissions (Substantially Equivalent/Not Substantially Equivalent), PMA/HDE approvals or denials, Breakthrough Device designation grants or denials, IDE approvals or disapprovals, protocol agreement failures, and clinical hold determinations.

Who can request a substantive summary under Section 517A?

Only persons who have submitted or are seeking to submit 510(k)s, PMAs, IDEs, HDEs, or Breakthrough Designation Requests can request substantive summaries for their own devices. Others must file FOIA requests for information about different devices.

What timeframes apply for supervisory review requests under Section 517A?

Requests must be submitted within 30 days of the decision. FDA must schedule meetings within 30 days and issue decisions within 45 days of the request, or 30 days after meetings/teleconferences.

How should I submit a request for substantive summary documentation?

Submit requests through CDRH’s Document Control Center via established premarket submission processes. Clearly label as “Request for Substantive Summary under 517A” and include the relevant submission number (e.g., 510(k) number).

What elements must be included in a substantive summary?

The summary must include the regulatory decision rationale, explanation of least burdensome requirements application, documentation of significant controversies and their resolution, and references to literature and consensus standards used.

Does Section 517A apply to all CDRH regulatory decisions?

No, Section 517A only applies to specific “significant decisions.” Non-517A decisions like requests for additional information, major deficiency letters, refuse-to-accept letters, and warning letters follow different procedures under 21 CFR 10.75.

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What You Need to Do 👇

Recommended Actions

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

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Relevant Guidances 🔗

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

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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 ID: 2f6ad4509a7cbd9040f37b3e54a62a9b