Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
This guidance outlines the Q-Submission (Q-Sub) Program, which provides mechanisms for medical device manufacturers to request feedback and meetings with FDA regarding medical device submissions. It covers various types of Q-Subs including Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and PMA Day 100 Meetings. The guidance aims to facilitate interactions between FDA and industry to improve the efficiency of the medical device review process.
This is a draft guidance. Not for implementation.
Recommended Actions
- Review applicable FDA guidance documents and standards before preparing Q-Sub
- Carefully plan submission timing to align with development program needs
- Limit scope to 3-4 substantial topics with focused questions
- Provide clear proposals with rationale rather than open-ended questions
- Include sufficient background information while avoiding extraneous content
- Submit meeting minutes within 15 days of any Q-Sub meeting
- Consider dependencies between questions when planning submissions
- Follow proper submission formatting and eCopy requirements
- Specify preferred feedback format (written and/or meeting)
- Track and reference previous FDA interactions in future submissions
- Submit new Pre-Sub if more than 1 year has passed since previous feedback
- Include draft agenda and multiple meeting date options when requesting meetings
Key Considerations
Clinical testing
- Clinical study protocols should be submitted with specific questions and rationale for chosen approach
- FDA feedback on clinical studies should be obtained prior to study initiation
- If more than 1 year has passed since previous FDA feedback on study design, confirm if advice is still applicable
- For OUS studies intended to support marketing applications, consider submitting full protocol for FDA feedback
Non-clinical testing
- Provide specific proposals with rationale for non-clinical testing approaches
- Include references to applicable guidance documents and standards
- Consider timing of FDA feedback requests to inform testing plans
- Clearly articulate intended outcomes and labeling claims to be supported
Human Factors
- Submit human factors test protocols for FDA review
- Include use-related risk analysis plans
- Specify test participant recruitment plans
- Identify critical tasks for evaluation
Software
- Specify software level of concern classification
- Document validation approach for emerging technologies
- Address multiple function device products appropriately
- Reference previously reviewed software documentation when applicable
Cybersecurity
- Identify and document attack vectors
- Provide cybersecurity management plans
- Specify risk models for cybersecurity assessment
- Define appropriate security controls based on device risk
Biocompatibility
- Justify test article selection for worst-case scenarios
- Propose chemical characterization approaches when appropriate
- Provide rationale for omitting specific biocompatibility tests
- Consider alternative test methods with proper justification
Labeling
- Submit test plans to support specific labeling claims
- Address reprocessing/cleaning validation for reusable devices
- Include protocols for MR Conditional labeling
- Provide validation for shelf-life claims
Safety
- Document sterilization validation approaches
- Address reprocessing requirements
- Validate shelf-life claims
- Consider worst-case testing scenarios
Other considerations
- Limit scope to 3-4 substantial topics per submission
- Submit no more than 7-10 focused questions
- Consider dependencies between questions
- Provide meeting minutes within 15 days
- Include appropriate background information
- Clearly identify the purpose and goals
- Specify preferred feedback format
- Follow submission formatting requirements
Relevant Guidances
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- ISO 11135-2014: Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
Original guidance
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