Home » FDA Tightens Controls for Surgical Mesh Used in Transvaginal Repairs
FDA Tightens Controls for Surgical Mesh Used in Transvaginal Repairs
The FDA wants to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse from Class II to Class III, high-risk devices. The agency also issued a draft order detailing PMA requirements for these devices, which have been linked to injuries resulting in numerous lawsuits against their manufacturers.
Devices & Diagnostics Letter
Drugs GMPs Regulatory AffairsDevices & Diagnostics Letter
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