GroundRules
21 CFR 880.5630: Nipple shield.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
- Subpart F—General Hospital and Personal Use Therapeutic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON