21 CFR 880.5760
§ 880.5760 Chemical cold pack snakebite kit.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5760, § 880.5760 Chemical cold pack snakebite kit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90556
- Permanent ID
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Full text
(a) Identification. A chemical cold pack snakebit kit is a device consisting of a chemical cold pack and tourniquet used for first-aid treatment of snakebites.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any chemical cold pack snakebite kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a chemical cold pack snakebite kit that was in commercial distribution before May 28, 1976. Any other chemical cold pack snakebite kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.