---
kind: "section"
citation: "21 C.F.R. § 880.5270"
title: "21"
number: "880.5270"
heading: "Neonatal eye pad."
url: "https://uscodex.org/cfr/21/880.5270"
---

# §880.5270. Neonatal eye pad.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 880.9](/cfr/21/880.9.md). 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](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025]