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“Reclassification,” U.S. Food and Drug Administration, September 22, 2025, https://www.fda.gov/about-fda/cdrh-transparency/reclassification; Notably, surgical mesh for prolapse repair, a high-profile case of 510(k) scrutiny with considerable social activism and class action lawsuits, was reclassified from Class II to Class III in 2017. Similarly, the surgical instrumentation associated with this technology was reclassified from Class I to Class II. In 2019, the FDA ordered all manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse to stop selling and distributing products. “Urogynecologic Surgical Mesh Implants,” U.S. Food and Drug Administration, August 16, 2021, https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants. Overall, there have been a total of 30 reclassifications reported by FDA; 24 have been classification downgrades and 6 have been classification upgrades.Google Scholar