21 CFR 864.9205 - Blood and plasma warming device.

§ 864.9205 Blood and plasma warming device.

(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.

[ 45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 864 after this date.

  • 2016-03-01; vol. 81 # 40 - Tuesday, March 1, 2016
    1. 81 FR 10553 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments by May 31, 2016. Please see section IV of this document for the proposed effective date of a final rule that may issue based on this proposal.
      21 CFR Part 864