Life-supporting or life-sustaining device used outside a device user facility

This category matters because FDA can require device tracking (21 CFR 821) and postmarket surveillance (21 CFR 822) for such devices. Physician's offices do not count as device user facilities, so a device used in a doctor's office or at home falls into this group.

Life-supporting or life-sustaining device used outside a device user facility means that a device is essential to, or yields information essential to, the restoration or continuation of a bodily function important to the continuation of human life and is used outside a hospital, nursing home, ambulatory surgical facility, or diagnostic or outpatient treatment facility. A physician's office is not a device user facility.

21 CFR, 822.3

Life-supporting or life-sustaining device used outside a device user facility means a device which is essential, or yields information that is essential, to the restoration or continuation of a bodily function important to the continuation of human life that is intended for use outside a hospital, nursing home, ambulatory surgical facility, or diagnostic or outpatient treatment facility. Physicians' offices are not device user facilities and, therefore, devices used therein are subject to tracking if they otherwise satisfy the statutory and regulatory criteria.

21 CFR, 821.3

Both definitions describe the same devices. The tracking rule (821.3) speaks of devices intended for use outside these facilities and adds that devices used in physicians' offices are subject to tracking if they meet the other criteria, while the postmarket surveillance rule (822.3) speaks of devices that are used outside them.