Medical device reporting is a federal regulation requiring manufacturers, importers, and user facilities (hospitals, nursing homes, etc) to report medical device-related adverse events (21 CFR Part 803). User facilities must report adverse events involving medical devices to 1 of 2 entities: the device manufacturer or the US Food and Drug Administration (FDA). Adverse events that result in serious injury or illness must be reported to the device manufacturer (or the FDA if the manufacturer is unknown), whereas adverse events that result in death must be reported to both the device manufacturer and FDA.
Corresponding author: Saphia Waheed, MS, 10903 New Hampshire Ave, White Oak Bldg 66, Silver Spring, MD 20993. She can be reached at Saphia.Waheed@fda.hhs.gov.
Saphia Waheed, MS, is a biomedical engineer in the Division of Patient Safety Partnerships, Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the US Food and Drug Administration.
James Swiger, MBE, is a supervisory biomedical engineer and deputy director of the Division of Patient Safety Partnerships in the Center for Devices and Radiological Health at the Food and Drug Administration in Silver Spring, Maryland. He earned his bachelor’s and master’s degrees in biomedical engineering from The Catholic University of America.
The authors declare no conflicts of interest.