part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"
subpart_code: "E"
subpart_subject: "Surgical Devices"
section_number: "878.4360"
section_subject: "Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia."
cfr_reference: "21 CFR 878.4360"
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"
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(a)Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
(b)Classification—Class II (special controls). The special controls for this device are:
(1)Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2)Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3)Software verification, validation, and hazard analysis must be performed.
(4)The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.