21 CFR 890.3665
§ 890.3665 Congenital hip dislocation abduction splint.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3665, § 890.3665 Congenital hip dislocation abduction splint, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91188
- Permanent ID
ys:prov:91188@1- SHA-256
97e4c8068d87274e4b01c09efdd4cca2d993db475ae0e31c82bbd75c160a39dd
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Full text
(a) Identification. A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).
(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.