21 CFR 880.5270
§ 880.5270 Neonatal eye pad.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5270, § 880.5270 Neonatal eye pad, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90532
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Full text
(a) Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.