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FDA & ABIA collaborate to develop regulatory science for use of biomaterials in medical devices



Published December 19, 2011
Austen BioInnovation Institute in Akron (ABIA) and the U.S. Food and Drug Administration (FDA) have entered into a collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.

The FDA and ABIA executed a memorandum of understanding that will allow the FDA to draw upon ABIA resources—including a library of test methods for crystalline polymers and advanced methods of nanoparticle-based surface defect detections—to 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 and ABIA established this partnership to develop the necessary research protocols and techniques that will standardize ways to evaluate existing or new materials, hybrids, composites and polymer-centric devices, which are anticipated to increase in the regulatory pipeline in the next few years.

The two groups said they expect to enhance the knowledge of materials development and behaviors, while increasing the capabilities that will aid regulatory agencies that classify, evaluate and monitor the safety and performance of new and existing products. The partnership is expected to generate polymer libraries in physical/structural properties; methods to characterize and predict solubility and degradation of polymers; and characterize the presence of bioactive bindings. Further, the partnership will look at the short- and long-term durability of flexible implantable devices to determine how coatings impact medical device performance.

ABIA is a collaboration of Akron Children's Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, The University of Akron (UA) and The John S. and James L. Knight Foundation and is focused on innovation and commercialization at the intersection of biomaterials and medicine. In addition to ABIA and its founding members, the assets involved in the agreement include ABIA's Medical Device Development Center, UA and joint ABIA-UA Akron Functional Materials Center. The partnership leverages the home of the world's largest polymer academic program and greatest concentration of polymer expertise at UA.


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