FDA and Austen BioInnovation Institute in Akron (ABIA) have entered into a groundbreaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices. As part of the agreement, FDA will 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 FDA's safety review of biomaterials used in medical devices.

Working with FDA, ABIA—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 whose focus is innovation and commercialization at the intersection of biomaterials and medicine—will identify and convene a steering committee to guide a process for scientific and intellectual partnerships, 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 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," says Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

“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," says Frank L. Douglas, ABIA President and CEO.

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.

FDA establishes external collaborative partnerships as one way to help achieve its 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 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.