21 C.F.R. § 890.3150 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — MEDICAL DEVICES — PHYSICAL MEDICINE DEVICES — PHYSICAL MEDICINE PROSTHETIC DEVICES — Crutch

(a) Identification. A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files.

21 C.F.R. §890.3150

48 FR 53047, 11/23/1983, as amended at 66 FR 38816, 7/25/2001