21 CFR 880.6050
§ 880.6050 Ice bag.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 880.6050, § 880.6050 Ice bag, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90566
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Full text
(a) Identification. An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.
(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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.