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

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

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