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

WASHINGTON, Dec. 15, 2011 /PRNewswire-USNewswire/ -- 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 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.

"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.

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 innovation and commercialization at the intersection of biomaterials and medicine. In addition to ABIA and its founding members, the assets involved in the agreement include ABIA's Medical Device Development Center, UA and joint ABIA-UA Akron Functional Materials Center. The partnership leverages the home of the world's largest polymer academic program and greatest concentration of polymer expertise at UA.

About the Austen BioInnovation Institute in Akron
The Austen BioInnovation Institute in Akron (ABIA) – an exceptional collaboration of Akron Children's Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, The University of Akron and The John S. and James L. Knight Foundation – is focused on patient-centered innovation and commercialization at the intersection of biomaterials and medicine. The strategic alignment of public and private support, accompanied with Akron's rich legacy in materials science, is working to pioneer the next generation of life-enhancing and life-saving innovation that will transform Akron into a model for biomedical discovery and enterprise and move the region toward a secure economic future by accelerating the creation of more than 2,000 jobs during the next decade. For more information about ABIA, please visit

Media Contact:
Scott Rainone
Office of Communications
Austen BioInnovation Institute in Akron

SOURCE Austen BioInnovation Institute in Akron
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Intellect Neurosciences Files Appeal in Europe in Response to Opposition Proceedings Instituted by Elan Pharmaceuticals and Wyeth/Pfizer
2. SRI International Awarded Contract Worth Up to $100M From National Institute of Allergy and Infectious Diseases
3. Molecular Imaging, Inc. Enters Relationship with Dana-Farber Cancer Institute to Expand Luciferase-reporter Cancer Cell Lines for Preclinical in vivo Imaging
4. IBM Contributes Data to the National Institutes of Health to Speed Drug Discovery and Cancer Research Innovation
5. The Food and Drug Law Institute to Present Distinguished Service and Leadership Awards to Andersen, Autor, Brady, Thirolf
6. Delcath Announces Agreement With European Institute of Oncology for Initial Launch of Hepatic Chemosat Delivery System in the European Union
7. Lilly Provides Additional Funding to Infectious Disease Research Institute to Identify New Tuberculosis Therapies
8. Russian Institute of Nutrition-Nutrilite Health Institute Collaboration Identifies Stress Markers Potentially Linked to Chronic Diseases in Overweight Russian Adults
9. Medco Research Institute Study Shows Some Patients Discontinue New Anticoagulant Drug Early, Which May Increase Stroke Risk
10. Novation Applauds the IMS Institute for Healthcare Informatics for Calling Attention to the Drug Shortage Crisis Facing American Hospitals
11. Panasonic Unveils Relationship with Cenegenics Medical Institute Featuring CardioHealth Station
Post Your Comments:
(Date:6/26/2016)... , June 26, 2016 One of Australia,s ... announced the formation of a new biotechnology company, Noxopharm Limited [ABN ... in an IPO and to list on the ASX. ... NOX66, ready to enter a Phase 1 clinical study later this ... to address one of the biggest problems facing cancer patients - ...
(Date:6/26/2016)... 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ... Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) expired ... Time). As previously announced on May 31, ... merger agreement under which Jazz Pharmaceuticals has commenced a ...
(Date:6/26/2016)...  VMS Rehab Systems, Inc. ( ) reported ... required to build a strong and stable market for ... on the OTC Markets-pink current trading platform. ... are seeing an anomaly in market trading activities that ... the Company, but shareholders and market players as well. ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... ... , the only authorized OSHA Training Institute Education Center headquartered in Northern California, ... their workers from extreme heat at their worksites. Employers with workers exposed ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... "FCPX editors ... customizable inside of Final Cut Pro X," said Christina Austin - CEO of Pixel ... style. Final Cut Pro X users can now reveal the media of ...
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... today its affiliation with Tennessee Counseling Association. This new relationship allows ... the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced its strategic partnership with Connance, a healthcare industry leader providing predictive ... proven, proprietary technology combine to provide health systems, hospitals and ambulatory surgical ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... to revolutionize the emergency ambulance transport experience for the millions of people who ... Uber has disrupted the taxi industry through the use of technology. Now, SmartEMS ...
Breaking Medicine News(10 mins):