---
kind: "section"
citation: "21 C.F.R. § 878.4490"
title: "21"
number: "878.4490"
heading: "Absorbable hemostatic agent and dressing."
url: "https://uscodex.org/cfr/21/878.4490"
---

# §878.4490. Absorbable hemostatic agent and dressing.

- (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](/cfr/21/515.md) of the act is required before this device may be commercially distributed. See [§ 878.3](/cfr/21/878.3.md).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.