FDA, Ohio Consortium to Partner on Biomaterials Regulations

(FDA.gov)

The U.S. Food and Drug Administration (FDA) and Austen BioInnovation Institute in Akron (ABIA) are collaborating on the development of regulations affecting biomaterials in medical devices. The consortium of Akron, Ohio area hospitals, universities, and foundations signed the partnership agreement with FDA yesterday.

The FDA and ABIA established the partnership to develop the research protocols and techniques for standardizing ways to review existing or new materials, hybrids, composites and polymer-centric devices, which are anticipated to increase in the next few years. The collaboration is one of several already joined by FDA in the agency’s Public-Private Partnerships Program.

The agreement will allow FDA to to draw upon ABIA resources to support the FDA’s safety review of biomaterials used in medical devices. Those resources include a library of test methods for crystalline polymers and processes for nanoparticle-based detections of surface defects.

The agreement between the two organizations is also expected to generate polymer libraries in physical and structural properties, methods to characterize and predict solubility and degradation of polymers, and characterize the presence of bioactive bindings.  In addition, the partnership will look at the short- and long-term durability of flexible implantable devices to determine how coatings impact medical device performance.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health says the partnership “will advance regulatory science by augmenting our capacity to examine and better understand engineered tissues, polymers, and coatings and to detect nanoparticle surface defects.”

ABIA is a consortium of Akron Children’s Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, The University of Akron, and The John S. and James L. Knight Foundation that encourages innovation and commercialization at the intersection of biomaterials and medicine.

Read more: FDA to Tap Outside Specialized Experts on Devices

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