21 C.F.R. § 878.4440

Eye pad.

Last amended: 2016Year: 2026Length: 89 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 878.4440 (2026)

(a) Identification. An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. (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 the limitations in § 878.9. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]
Cross-references to the CFR
878.9.
21 C.F.R. § 878.4440: Eye pad. | Justis AI