Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)

This is a draft guidance. Not for implementation.

What You Need to Know? 👇

What is the Q-Submission Program and how does it benefit medical device companies?

The Q-Submission Program is FDA’s mechanism for tracking interactions between industry and the Agency regarding medical device submissions. It includes Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and PMA Day 100 Meetings. This voluntary program helps improve submission quality, shorten review times, and facilitate device development through early FDA feedback.

How long does FDA take to provide feedback on Pre-Submissions?

FDA provides written feedback within 70 calendar days from receipt of an accepted Pre-Submission. If a meeting is requested, written feedback is provided at least 5 days before the scheduled meeting. Meetings are typically scheduled between days 70-75, and FDA aims to reach agreement on meeting dates within 30 days of submission receipt.

What types of questions are most appropriate for Pre-Submissions versus informal communications?

Pre-Submissions are best for specific questions requiring in-depth review about planned studies, testing protocols, or regulatory approaches for future submissions. Informal communications are appropriate for administrative questions, simple clarifications, general FDA policy inquiries, or questions readily answered based on reviewer experience without requiring additional background information or staff involvement.

When should I submit a Submission Issue Request (SIR) and what are the timelines?

Submit a SIR to discuss approaches for addressing issues in FDA hold letters, including Additional Information Needed letters, Major Deficiency letters, or Complete Response Letters. FDA aims to provide feedback within 21 days if submitted within 60 days of the FDA letter, or 70 days if submitted later, as resources permit.

How many questions should I include in a single Pre-Submission for optimal feedback?

FDA recommends limiting Pre-Submissions to 3-4 substantial topics with no more than 7-10 total questions (including sub-questions). This allows for thorough review and valuable feedback. Substantial topics include areas like biocompatibility, clinical study design, or software validation. Too many questions can lead to less productive discussions and interdependent feedback issues.

What are the key requirements for meeting minutes in Q-Submission meetings?

Submitters must draft meeting minutes within 15 days of any Q-Sub meeting and submit them as an amendment. Minutes should summarize discussions, document issue resolutions, include agreements and action items, but not assign statements to individuals. They should reflect meeting content accurately without being transcripts, and exclude post-meeting information not discussed during the actual meeting.

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What You Need to Do 👇

Recommended Actions

1. Review applicable FDA guidance documents and standards before preparing Q-Sub
2. Carefully plan submission timing to align with development program needs
3. Limit scope to 3-4 substantial topics with focused questions
4. Provide clear proposals with rationale rather than open-ended questions
5. Include sufficient background information while avoiding extraneous content
6. Submit meeting minutes within 15 days of any Q-Sub meeting
7. Consider dependencies between questions when planning submissions
8. Follow proper submission formatting and eCopy requirements
9. Specify preferred feedback format (written and/or meeting)
10. Track and reference previous FDA interactions in future submissions
11. Submit new Pre-Sub if more than 1 year has passed since previous feedback
12. 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

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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

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Original guidance

• Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings
• HTML / PDF
• Issue date: 2024-03-15
• Last changed date: 2024-03-14
• Status: DRAFT
• Official FDA topics: Medical Devices, Administrative / Procedural, Premarket, Biologics
• ReguVirta ID: e9137b1c5c4a92ffde91f42458caace8