21 CFR §878.4456
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
- (b)Classification. Class II (special controls). The special controls for this device are:
- (1)The device must be demonstrated to be biocompatible.
- (2)Performance data must support the sterility and pyrogenicity of the device.
- (3)Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
- (4)In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
- (i)The ability to deliver the hemostatic material to the bleeding site;
- (ii)The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
- (iii)Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
- (5)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
- (i)Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
- (ii)Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
- (6)Labeling must include: