21 CFR 876.5970
§ 876.5970 Hernia support.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 876.5970, § 876.5970 Hernia support, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90369
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Full text
(a) Identification. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.
(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 § 876.9. 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.