GroundRules
21 CFR 864.9205: Blood and plasma warming device.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON