WASHINGTON, D.C., Dec. 15, 2011 Austen BioInnovation Institute in Akron (ABIA) and the U.S. Food and Drug Administration (FDA) have entered into a ground-breaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.
Effective today, the FDA and ABIA executed a Memorandum of Understanding that will allow the FDA to draw upon ABIA resourcesincluding a library of test methods for crystalline polymers and advanced methods of nanoparticle-based surface defect detectionsto develop combinatorial and high throughput methods to support the FDA's safety review of biomaterials used in medical devices.
Working with the FDA, ABIA will identify and convene a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives. The steering committee will create a path for joint education and research meetings, and support research collaborations in applied biomaterials, including ways to share unique facilities and equipment specific to the review of biomaterials. The formal Memorandum of Understanding is the first between the FDA and the Akron, Ohio-based ABIA.
"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," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
"Our partnership with ABIA will advance regulatory science by augmenting our capacity to examine and better understand engineered tissues, polymers, and coatings and to detect nanoparticle surface defects," said Shuren.
"We have been impressed with the tremendous professionalism and openness of the Center of Devices and Radiological Health team in working with us to establish this partnership," said Dr. Frank L. Douglas, ABIA President and CEO.
|Contact: Scott Rainone|
Austen BioInnovation Institute in Akron