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FDA, ABIA to collaborate on safety and performance of materials used in medical devices

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. "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.


Contact: Scott Rainone
Austen BioInnovation Institute in Akron

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