JonnaLynn Capezzuto
Office of Operations
U.S. Food and Drug Administration
Three White Flint North, 10A–12M
11601 Landsdown St.,
North Bethesda, MD 20852
Subject: Food and Drug Administration (FDA) Adverse Event and Product Experience Reporting Program Comment Request (Docket No. FDA–2024–N–5468).
Dear Ms. Capezzuto,
On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), we appreciate the opportunity to respond to the agency information collection associated with the U.S. Food and Drug Administration (FDA) adverse event and product experience reports. The AANS/CNS Committee on Drugs and Devices has recently established a workgroup to examine the experience of neurosurgeons with the FDA Manufacturer and User Facility Device Experience (MAUDE) database. We are eager to provide feedback to the FDA on this issue and to better educate our members on the process of reporting adverse events with regulated products.
Read the full letter here.
