A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.
Although a user facility is not required to report a device malfunction, they can voluntarily inform the FDA of such product problems through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.