Merrill Goozner
First posted 7/29/11 on Gooz News
The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called this morning for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.
Continue reading “IOM Calls For Overhaul of Device Regulation”