21 CFR 888.5960
§ 888.5960 Cast removal instrument.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.5960, § 888.5960 Cast removal instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91151
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Full text
(a) Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.
(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 § 888.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.