Code of Federal Regulations Title 21. Food and Drugs § 21.890.3640 Arm sling

(a) Identification. An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

(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.