21 CFR 864.9205 - Blood and plasma warming device.

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There are 2 Updates appearing in the Federal Register for 21 CFR 864. View below or at eCFR (GPOAccess)
§ 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864