The U.S. Food and Drug Administration on Aug. 5 issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” says Jeffrey Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”
