21 CFR 890.3490
§ 890.3490 Truncal orthosis.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 890.3490, § 890.3490 Truncal orthosis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91183
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Full text
(a) Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
(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.