FDAnews
www.fdanews.com/articles/143237-fda-asks-tv-mesh-manufacturers-to-conduct-postmarket-studies

FDA Asks TV Mesh Manufacturers to Conduct Postmarket Studies

January 17, 2012
Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act. The agency ordered 33 surgical mesh manufacturers to conduct the studies as it intensifies its investigation into complications associated with transvaginal placement of surgical mesh.
Devices & Diagnostics Letter