GroundRules
21 CFR 878.3925: Plastic surgery kit and accessories.
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. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
(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 § 878.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON