Device User Facility Law and Legal Definition

According to 21 CFR 803.3 (Title 21 -- Food And Drugs; Chapter I - Food And Drug Administration, Department Of Health And Human Services; Subchapter H - Medical Devices; Part 803 - Medical Device Reporting Subpart A - General Provisions), 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.”