21 C.F.R. § 880.5630 Nipple shield.
Title 21 - Food and Drugs
(a) Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (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 §880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 33804, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5630 Nipple shield.
