FDA to relax regulatory requirements

By: Trialmed editor

Aug 19, 2011

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products. Specifically, a number of device types will now be exempt from pre- market notification requirements. The FDA move, which affects approximately 30 medical device types ranging from radiology film processors to blood testing, was prompted by the long track record of safety and effectiveness of each respective product. CDRH Director Jeffrey Shuren stated that “the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers,” without risking the health of the public in the process. The FDA has also stated that this is the first step in what will be a gradual loosening of 510(k) requirements across the board for low-risk radiology and in vitro diagnostic devices. Until this occurs, the FDA will exercise what it calls “enforcement discretion” in handling pre-market notification submissions for the 30 medical device types described within the document. There is as of yet no timetable for the adoption of this dramatic shift in medical device regulatory approval standards, but a 90-day comment period on the proposal is currently in effect.