21 CFR 878.4490
§ 878.4490 Absorbable hemostatic agent and dressing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4490, § 878.4490 Absorbable hemostatic agent and dressing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90436
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.