Bill Could Facilitate Tracking of Implants Approved Via 510(k)

If a newly submitted bill is passed into law, it could force devicemakers to conduct more postmarket studies after 510(k) clearance. But industry groups are against such a move. The Medical Device Patient Safety Act (S. 1995), co-sponsored by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would allow the U.S. Food and Drug Administration (FDA) to require that companies track implants and other high-risk devices that were approved without human testing.
International Medical Device Regulatory Monitor