GroundRules
21 CFR 878.4490: Absorbable hemostatic agent and dressing.
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 E—Surgical Devices
(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.
Collected 2026-08-27T02:24:47Z. Source file · JSON