Outpatient diagnostic facility

Under 21 CFR 803 these facilities are device user facilities, so they have Medical Device Reporting duties for device-related deaths and serious injuries. Imaging centers and testing laboratories are typical examples.

Outpatient diagnostic facility means: (1) A distinct entity that: (i) Operates for the primary purpose of conducting medical diagnostic tests on patients, (ii) Does not assume ongoing responsibility for patient care, and (iii) Provides its services for use by other medical personnel. (2) Outpatient diagnostic facilities include outpatient facilities providing radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in vitro testing. An outpatient diagnostic facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.

21 CFR, 803.3