Developing and Responding to Medical Device Marketing Application Deficiencies

What You Need to Know? 👇

What are the key elements that must be included in an FDA deficiency letter for medical device submissions?

An effective deficiency must include four elements: acknowledgment of submitted information, identification of specific issues, statement of basis for the deficiency including impact on marketing authorization, and explicit request for additional information with potential alternatives.

How do the Least Burdensome Provisions affect FDA’s approach to requesting additional information?

The Least Burdensome Provisions require FDA to request only the minimum necessary information for marketing authorization decisions, consider alternative approaches, and balance premarket versus postmarket data collection while maintaining safety and effectiveness standards.

What is the difference between major and minor deficiencies in FDA deficiency letters?

Major deficiencies are issues that, if unresolved, will preclude favorable marketing authorization and must be addressed for final decisions. Minor deficiencies can be resolved straightforwardly but need addressing to meet regulatory requirements or prevent misbranding.

How should medical device companies structure their responses to FDA deficiency letters?

Companies should restate the identified Agency issue and provide either the requested information/data, explain why the issue doesn’t affect marketing authorization, or offer alternative information with justification for adequately addressing the concern.

What role does supervisory review play in FDA deficiency letter development?

Supervisory review ensures deficiencies are relevant to marketing authorization decisions, include required elements, prioritize significant issues first, and verify appropriate inclusion of specific references when available, applicable, and relevant.

When does FDA use interactive review versus formal deficiency letters for medical device submissions?

FDA uses interactive review for minor deficiencies and additional considerations via phone or email without placing submissions on hold. Formal deficiency letters include major issues and officially place marketing applications on hold pending response.

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What You Need to Do 👇

Recommended Actions

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

• 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:
  • Restate the FDA issue
  • Provide requested information OR explain why issue doesn’t affect decision OR provide alternative information
  • Include justification of how response addresses FDA’s concerns

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Relevant Guidances 🔗

• Least Burdensome Principles for Medical Device Regulation
• Types of Communication During Medical Device Submissions Review
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development

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

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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 ID: 7cd5eb84cc8214413028881ed80d35f1