eCFR Reference Browser

---

title: "21 CFR §880.5700"

source: "https://www.ecfr.gov/current/title-21/section-880.5700"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "880"

part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"

subpart_code: "F"

subpart_subject: "General Hospital and Personal Use Therapeutic Devices"

section_number: "880.5700"

section_subject: "Neonatal phototherapy unit."

cfr_reference: "21 CFR 880.5700"

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 neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

(b)Classification. Class II (performance standards).

§880.5700 - Neonatal phototherapy unit.