The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles. The draft guidance lists 30 different device types, including common urine and blood tests, alcohol breath tests, blood clotting protein tests, and radiology device accessories, such as film cassettes, film processors, and digitizers. FDA intends to exempt these devices from premarket notification requirements through the appropriate regulatory processes.
