FDA Draft Guidance: Types of Communication During the Review of Medical Device Submissions | Regulatory Doctor

FDA Draft Guidance: Types of Communication During the Review of Medical Device Submissions – Draft Guidance for Industry and Food and Drug Administration Staff | Regulatory Doctor

Table of Contents

  1. Introduction
  2. Scope
  3. Acceptance Review Communication
    1. Purpose of Acceptance Review Communication
    2. Timing of Acceptance Review Communication
    3. Content of Acceptance Review Communication
  4. Substantive Interaction
    1. Purpose of Substantive Interaction
    2. Timing of Substantive Interaction
    3. Content of Substantive Interaction
  5. Interactive Review
    1. Purpose of Interactive Review
    2. Types of Deficiencies Appropriate for Interactive Review
    3. Timing of Interactive Review
    4. Communication Tools for Interactive Review
    5. Responses to Deficiencies Requested via the Interactive Review Process
    6. Applicant’s Role in the Interactive Review Process.
    7. FDA Review Team Considerations
  6. Missed MDUFA Decision Communication
    1. Purpose of Missed MDUFA Decision Communication.
    2. Timing of Missed MDUFA Decision Communication.
    3. Content of Missed MDUFA Decision Communication.

via FDA Draft Guidance: Types of Communication During the Review of Medical Device Submissions | Regulatory Doctor.

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