Technical documentation facilitates FDA-compliant product developments
Weinheim, July 07, 2021 – Viscofan BioEngineering, the business unit for biomedical research and development of Naturin Viscofan GmbH has submitted Master File documentation (MAF) for Viscolma® collagen suspension to The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
The FDA has established the master file system to facilitate sound scientific evaluation of medical device developments that require another party’s product. MAF documents enable the review of data and other information by preserving the trade secrets of the external product.
As Lluis Quintana, Corporate Director of Viscofan BioEngineering states: “The MAF will ensure our U.S.-collaborators needing medical grade collagen suspension that Viscofan BioEngineering will work directly with the FDA for compliance. They can now use MAF for their technical documentation on Viscolma® to facilitate FDA-applications.”
Medical grade Viscolma® is a suspension of ultrapure collagen type I fibers extractedfrom bovine skin in a highly standardized industrial process under ISO 13485 certified quality management. The insoluble collagen fibers retain their highly native structure and represent a natural 3D-scaffold for cells, promoting attachment, growth and differentiation. The putty-like Viscolma® contains up to 15% collagen in water and exhibits excellent biocompatibility and biodegradability.
The unique features of this natural collagen suspension enable broad medical use, such as the development of products and therapies in regenerative medicine, tissue engineering, medical device technology, implantology, ATMPs (Advanced Therapy Medicinal Products), or as bioink in 3D bioprinting.
Viscolma® is also the raw material for all of Viscofan BioEngineering’s collagen membranes and together with partners, the company is developing its own innovative pipeline, currently having several products in preclinical and clinical testing. Lluis Quintana is looking ahead: “We intend to expand collaborations to enable breakthroughs in medical engineering and regenerative medicine.”