Frequently Asked Questions

How do you prepare a 510(k) using the safety and performance based pathway?

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Compliance & Regulatory: MedTech
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Guidelines & Standards

The amount and type of information necessary to support a finding of substantial equivalence under the Safety and Performance Based Pathway will depend on the underlying source for the performance criteria and testing methods. Submitters should refer to relevant device-specific Safety and Performance Based Pathway guidance for more information. The FDA recommends submitters clearly state in their 510(k) cover letter that their submission is intended for the Safety and Performance Based Pathway.

Importantly, 510(k) submitters still need to identify a predicate for certain aspects of substantial equivalence. However, instead of conducting direct comparison testing to demonstrate a device is as safe and effective as a predicate device, manufacturers will have the option to use this pathway to demonstrate substantial equivalence, when appropriate.