eCFR Reference Browser

---

title: "21 CFR §878.4490"

source: "https://www.ecfr.gov/current/title-21/section-878.4490"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "878"

part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "878.4490"

section_subject: "Absorbable hemostatic agent and dressing."

cfr_reference: "21 CFR 878.4490"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§878.4490 - Absorbable hemostatic agent and dressing.