Medical Devices Need Follow Up After US Approval, Senators Say

Posted 21 December 2011 | By

On Thursday, 15 December, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the "Medical Device Patient Safety Act."  This bill contains two distinct proposals:  (1) to give the US Food and Drug Administration (FDA) the authority to track and trend device recalls, and (2) to allow FDA to grant conditional clearances for devices that will be subject to post-market requirements. Under the legislation, the FDA could order companies to conduct safety studies of devices after they're approved and could grant conditional approvals pending the result of ongoing trials. This measure would strengthen rules for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market. (Bloomberg)


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