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.
Recommended Actions
- Implement a deficiency letter template that includes the 4 required elements
- Establish supervisory review process for deficiency letters
- Prioritize deficiencies based on significance in letters
- Use interactive review for minor deficiencies whenever possible
- Structure industry responses to clearly restate and address each deficiency
- Include appropriate references to standards/guidance when applicable
- Provide clear justification when proposing alternative approaches
- Ensure responses are complete and submitted within specified timeframes
- Consider least burdensome approaches when developing deficiencies and responses
- Maintain focus on information necessary for marketing authorization decisions
Key Considerations
Other considerations
- Deficiency letters must include 4 key elements:
- What was submitted
- Identification of specific issue/concern
- Statement of basis for the deficiency
- Explicit request for additional information needed
- Major deficiencies are those that would preclude a favorable marketing authorization decision
- Minor deficiencies should be resolved through interactive review when possible
- Deficiency letters must undergo supervisory review
- Industry responses should:
- Least Burdensome Principles for Medical Device Regulation
- Types of Communication During Medical Device Submissions Review
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- 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
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