Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology

Published: 1993-02-09

Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Premarket Docket: FDA-2020-D-0957

Official Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-notifications-biopsy-devices-used-gastroenterology-and-urology

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