ASTM F3089-23

1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.

1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produced through in vitro cell culture, with or without using recombinant technology; and (3) chemically synthesized collagen mimetic peptides. It should be noted that the format of collagen polymeric material products also will vary and may include injectable solutions that polymerize in situ as well as preformed sheets, particles, spheres, fibers, sponges, matrices/gels, coatings, films, and other forms.

1.2.3 This guide may serve as a template for characterization and standardization of type I fibrillar collagen or other collagen types that demonstrate polymerization or self-assembly.