part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"
subpart_code: "E"
subpart_subject: "Surgical Devices"
section_number: "878.4454"
section_subject: "Non-absorbable, hemostatic gauze for temporary internal use."
cfr_reference: "21 CFR 878.4454"
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"
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(a)Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i)Demonstrate that the device is able to achieve hemostasis;
(ii)Demonstrate that the device can be radiographically detected; and
(iii)Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2)The device must be demonstrated to be biocompatible.
(3)Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(vi)Mechanical integrity testing, including tensile strength and tear strength.
(4)Performance data must demonstrate the sterility of the device.
(5)Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.