21 CFR 864.9205
§ 864.9205 Blood and plasma warming device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9205, § 864.9205 Blood and plasma warming device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89416
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Full text
(a) Nonelectromagnetic blood or plasma warming device—(1) Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.
(2) Classification. Class II (performance standards).
(b) Electromagnetic blood and plasma warming device—(1) Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.
(2) Classfication. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.