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FDA Reclassification of Surgical Instrumentation

posted: January 10, 2017

As anticipated, the FDA reclassified the surgical instrumentation for use with urogynecological surgical mesh from class I (general controls) to class II (special controls) effective January 6, 2017.

This reclassification means that manufacturers of surgical devices used for both SUI and POP procedures used in conjunction with mesh (ie. trocars, needle passers, etc.) that were approved before January 6, 2017 have one year to present data demonstrating safety and effectiveness in non-clinical performance testing during expected use conditions.  Specific additional clinical testing is not required.  Manufacturers of new devices will need to supply this information to the FDA prior to being approved.

SUFU, together with the AUA, supported the recommendations of the Gastroenterology-Urology Medical Devices Advisory Committee Panel that initially formed an Executive Summary Document in February 2016 regarding this reclassification.    SUFU believes that implementation of this reclassification will only serve to improve the care we can deliver to our patients, and ensure the safety of future devices.

For those interested, please see the initial Executive Summary of the Advisory Panel.

You may also view the current reclassification document, which discusses the entire FDA process and other specifications of the reclassification.