GroundRules
21 CFR 878.3590: Ear prosthesis.
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 878—GENERAL AND PLASTIC SURGERY DEVICES
- Subpart D—Prosthetic Devices
(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
(b) Classification. Class II.
Collected 2026-08-27T02:24:47Z. Source file · JSON