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Developing and Responding to Medical Device Marketing Application Deficiencies

This guidance is intended to help FDA review staff and supervisors develop deficiencies for medical device marketing applications (510(k), PMA, HDE, De Novo), as well as help industry prepare responses to deficiency letters. It focuses on the format and content of deficiency letters and responses, but does not apply to interactive review, IDEs, 513(g) requests, or Q-Submissions.

  1. Implement a deficiency letter template that includes the 4 required elements
  2. Establish supervisory review process for deficiency letters
  3. Prioritize deficiencies based on significance in letters
  4. Use interactive review for minor deficiencies whenever possible
  5. Structure industry responses to clearly restate and address each deficiency
  6. Include appropriate references to standards/guidance when applicable
  7. Provide clear justification when proposing alternative approaches
  8. Ensure responses are complete and submitted within specified timeframes
  9. Consider least burdensome approaches when developing deficiencies and responses
  10. Maintain focus on information necessary for marketing authorization decisions

Key Considerations

Other considerations

  • IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
  • ISO 10993-23: Biological evaluation of medical devices — Part 23: Tests for irritation

Original guidance

  • Developing and Responding to Medical Device Marketing Application Deficiencies
  • HTML / PDF
  • Issue date: 2022-10-26
  • Last changed date: 2022-10-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA)
  • ReguVirta summary file ID: 7cd5eb84cc8214413028881ed80d35f1
This post is licensed under CC BY 4.0 by the author.