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FDA, Austen BioInnovation Institute to Collaborate on the Safety and Performance of Materials used in Medical Devices
Date:12/15/2011

said Dr. Frank L. Douglas, ABIA President and CEO. "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."  

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 FDA establishes external collaborative partnerships as one way to help achieve their mission of protecting and promoting public health. Through FDA's Public-Private Partnerships Program, the agency is able to leverage the expertise and resources of both the FDA and qualified parties as an "economically compelling" way to assist in making sound regulatory decisions.

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 unique 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 i
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SOURCE Austen BioInnovation Institute in Akron
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