21 CFR 880.5700
§ 880.5700 Neonatal phototherapy unit.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5700, § 880.5700 Neonatal phototherapy unit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90552
- Permanent ID
ys:prov:90552@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.