Device user facility

User facilities must report device-related deaths and serious injuries under 21 CFR 803. Manufacturers often learn of events through these reports, so their complaint handling should expect them.

Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices and employee health units are not device user facilities.

21 CFR, 803.3