FDA proposes electronic 510(k) submission template

By AuntMinnie.com staff writers

February 26, 2020 -- The U.S. Food and Drug Administration (FDA) is considering a new optional electronic 510(k) submission template designed to better organize information in submissions for scientific review.

The agency will select up to nine participants to represent the medical device industry and submit medical device applications to the FDA using the PDF-based, electronic template.

The interactive template still requires the same product data and is complementary to the internal review templates currently used for 510(k) applications by the U.S. Center for Devices and Radiological Health.

The electronic submission template and resource (eSTAR) template will be released as part of the FDA's eSTAR pilot program to improve overall agency productivity and allow staff more time and resources to evaluate applications for devices that pose the highest potential risks to patients.


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