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Focus on Regulation

FDA Strengthens Requirements for Surgical Instrumentation Used with Urogynecologic Surgical Mesh

Effective January 6, 2017, the U.S. Food and Drug Administration (FDA) reclassified surgical instrumentation for use with urogynecologic surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class I (general controls) devices to class II (special controls) devices.

Surgical mesh—and the instrumentation for its administration—have been used for the transvaginal repair of POP since the 1980s. The first surgical mesh with this indication was cleared by FDA as a class II, moderate-risk device in 2002. In recent years, FDA has received thousands of reports of complications involving the use of surgical mesh for transvaginal POP repair. In response, the agency reclassified surgical mesh for transvaginal POP repair from class II to class III on January 5, 2016. However, FDA delayed the reclassification of the associated surgical instrumentation until after an Advisory Panel could be convened to discuss the proposal.

The promised meeting of the Gastroenterology-Urology Devices Panel was held on February 26, 2016. The discussion centred on FDA’s new analysis of perioperative adverse events (such as organ perforation, hemorrhage and bleeding, nerve injury and pain), which concluded that these events are related to the use of specialized surgical instrumentation during the procedure. The panel concluded that general controls alone are not sufficient to provide reasonable assurance of safety and effectiveness of these devices and recommended their reclassification to class II (special controls).

FDA’s final rule follows this recommendation and identifies these devices as ‘‘specialized surgical instrumentation for use with urogynecologic surgical mesh.’’ In keeping with the recommendations in its December 20, 2016, final guidance entitled “Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types,” FDA has not placed the instrumentation into the parent device classification, as these devices do not meet the definition of a class III device and are more appropriately regulated as class II devices.

Special controls for these devices are set forth in 21 C.F.R. § 884.4910. These special controls include requirements for (1) a demonstration that reusable devices can be adequately reprocessed (21 C.F.R. § 884.4910(b)(2)); and (2) nonclinical performance testing demonstrating that the device: (1) Meets all design specifications and performance requirements and (2) performs as intended under anticipated conditions of use (21 C.F.R. § 884.4910(b)(4)).

*A special thanks to Stefan Mayr for his assistance with this posting.