eCFR Reference Browser

---

title: "21 CFR §870.5900"

source: "https://www.ecfr.gov/current/title-21/section-870.5900"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "F"

subpart_subject: "Cardiovascular Therapeutic Devices"

section_number: "870.5900"

section_subject: "Thermal regulating system."

cfr_reference: "21 CFR 870.5900"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§870.5900 - Thermal regulating system.