FDA, Austen BioInnovation Institute to Collaborate on the Safety and Performance of Materials used in Medical Devices

Austen BioInnovation Institute (ABIA) will collaborate with FDA to support and develop regulatory science for the safe, effective use of biomaterials in medical devices. The partnership will develop research protocols and techniques that will standardize the evaluation of existing and new materials, hybrids, composites and polymer-centric devices.

Effective today, 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.

Source: Austen BioInnovation Institute

 

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