21 CFR 890.3410
§ 890.3410 External limb orthotic component.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3410, § 890.3410 External limb orthotic component, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91178
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Full text
(a) Identification. An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
(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.