AKRON, OHIO (Dec. 16, 12:45 p.m. ET) — Austen BioInnovation Institute in Akron and the U.S. Food and Drug Administration have signed an agreement that lays the groundwork for the organizations to work together to develop methods for the safe handling and use of biomaterials in medical devices.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a news release that the partnership will allow the FDA to use the Austen BioInnovation Institute's resources to enhance the agency's expertise in biomaterials, hybrids, composites and polymers.
“The FDA can better fulfill its commitment to protect and promote public health if it draws upon the intellectual resources, laboratory capacity and research capabilities that reside in academic centers such as ABIA,” Dr. Shuren said.
The memorandum of understanding is the first between Austen BioInnovation Institute and FDA.
“Given the rapid advances in the technology and development of biomaterials, we anticipate that ABIA will be able to bring sophisticated technologies to the FDA, enhancing the agency's knowledge and expertise in regulatory science as it applies to characterizing and predicting the performance of novel materials in biomedical devices,” Dr. Frank Douglas, president and CEO of the Austen BioInnovation Institute, said in the release.