GroundRules
21 CFR 870.5900: Thermal regulating system.
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 870—CARDIOVASCULAR DEVICES
- Subpart F—Cardiovascular Therapeutic Devices
(a) Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON