Division of Clinical Research

Office of the Vice President and Innovation

The U.S. Food and Drug Administration (FDA) issued three final guidance documents providing performance criteria for the following device types in support of the Safety and Performance Based Pathway:

Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria as identified in final guidance to support substantial equivalence, rather than completing a direct comparison of the performance of the subject device to that of a predicate device.

These guidances are the latest final guidances issued under the Safety and Performance Based Pathway and support the FDA’s goal of strengthening and modernizing the 510(k) medical device program.  The FDA strongly encourages industry and stakeholders to continue providing the FDA with recommendations for additional types of devices that would benefit from inclusion in future guidances regarding performance criteria and testing methodologies for the Safety and Performance Based Pathway using the docket number FDA-2018-D-1387 at www.regulations.gov.

Categories FDA Regulatory, Policies & Guidance
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