When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
This guidance provides recommendations for when clinical data may be needed to demonstrate substantial equivalence (SE) in 510(k) submissions. It aims to improve predictability, consistency, and transparency of the 510(k) review process by expanding on scenarios where clinical data may be necessary, while following least burdensome principles. The guidance applies to devices subject to 510(k) review by CDRH and CBER but does not address combination products or supersede device-specific guidance.
This is a draft guidance. Not for implementation.
Recommended Actions
- Review the four scenarios requiring clinical data:
- Differences in indications for use
- Differences in technological characteristics
- Inadequate non-clinical testing
- Newly identified/increased risks for predicate device
- Evaluate if your device falls under any scenario requiring clinical data
- Consider submitting a pre-submission to discuss specific questions with FDA review division
- Ensure clinical data constitutes valid scientific evidence per regulations
- Provide adequate justification if using data from comparable devices
- Review public FDA communications about new/increased risks for predicate devices
- Consider alternative predicate devices without new/increased risks when possible
- Consult device-specific guidance documents when available
Key Considerations
Clinical testing
- Clinical data may be needed to determine if new/modified indications fall within same intended use as predicate device
- Clinical data should constitute valid scientific evidence as defined in 21 CFR 860.7(c)(2)
- Data can include pre/post-market clinical investigations, literature, clinical experience reports, registries, adverse event databases, medical records
- Adequate justification needed when using data from comparable devices
Non-clinical testing
- When non-clinical testing is inadequate to establish SE due to:
- No available model (analytical, bench, animal)
- Model limitations preventing adequate assessment
- Model not predictive of clinical outcomes
- Anatomical/pathophysiological species-specific questions requiring clinical evidence
Labelling
- Proposed labeling used to determine device’s intended use
- Indications for use statement reviewed to determine if new device has same intended use as predicate
Safety
- New/increased risks identified for predicate device may require clinical data for new device
- Safety concerns identified through recalls and postmarket surveillance may trigger clinical data requirements
Other considerations
- Differences in technological characteristics requiring clinical data assessment:
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms
- 21 CFR 860.7(c)(2): Definition of valid scientific evidence
- 21 CFR 807.92(a)(5): General/Specific Intended Use
Original guidance
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