The FDA will be reviewing legacy medical devices, those whose use was grandfathered in since they were on the market before the medical device law was established in 1976, reports the New York Times. In the '70s, Congress had instructed FDA to eventually look over the legacy devices and determine which ones would need testing if and when a new version were to come out. However, this past January, the Government Accountability Office said in a report that FDA has not lived up to that request, as it left 27 types of devices unreviewed. The agency said yesterday that it was requiring makers of 25 types of devices (two having been reviewed since January) to submit product safety and effectiveness information to the agency within 120 days.
Yeah, Yeah, We'll Get to It Eventually
Apr 09, 2009