GUIDANCE DOCUMENT
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission Draft Guidance for Industry and Food and Drug Administration Staff September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-3134
- Docket Number:
- FDA-2023-D-3134
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is issuing this draft guidance to provide our current thinking on the use of best practices in selecting a predicate device in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance propose factors for consideration as best practices for choosing a predicate device that focus on characteristics of the predicate, including selecting a predicate device that was cleared using well-established methods, meets or exceeds expected safety and performance, is without unmitigated use-related or design-related safety issues, and is without an associated design-related recall. FDA believes use of these best practices will encourage the evolution of safer and more effective medical devices in the 510(k) Program over time.