Neurosurgery Response to FDA on Adverse Event Reporting

The FDA released a request for comments on the agency’s Adverse Event and Product Experience Reporting Program in January. On March 18, the AANS and the CNS sent a letter in response. The letter, drafted by the AANS/CNS Drugs and Devices Committee, highlights the importance of the FDA Manufacturer and User Facility Device Experience (MAUDE) database for tracking medical device safety, outlines challenges with its usability and reporting burden, and offers recommendations to enhance its functionality and accessibility for neurosurgeons.