The Food and Drug Administration of the US (FDA) has entered into a collaborative agreement with Austen BioInnovation Institute in Akron (ABIA) for the support and development of regulatory science related to the efficient use of biomaterials in medical devices.
As per the Memorandum of Understanding, the FDA will use resources of ABIA such as a library consisting of crystalline polymer test methods and methods for the detection of surfaces based on nanoparticles. The main focus of this agreement is to come up with a combination of methods for the review of biomaterials in medical devices by the FDA.
ABIA will work along with the FDA to set up a steering committee, which will help in laying out a process guideline for scientific collaborations, ventures, outreach and educational programmes. The steering committee will be responsible for conducting education and research meetings jointly and formulating ways to share equipment and facilities in terms of biomaterials. According to the FDA and the ABIA, this collaboration will help in enhancing the expertise on the development and behaviour of materials and will also equip regulatory agencies in the classification, evaluation and monitoring of safety of the current and new products and their performance. In relation to crystalline polymers, the partnership will specifically look at creating libraries for structural and physical properties, methods for predicting and degrading polymers and detecting the presence of bioactive bindings. The partnership will also study the impact of coatings on medical devices.