Navigation Links
FDA, ABIA to collaborate on safety and performance of materials used in medical devices
Date:12/15/2011

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
srainone@abiakron.org
330-572-7581
Austen BioInnovation Institute in Akron
Source:Eurekalert

Related biology news :

1. Scripps and Complete Genomics to collaborate on genetic research study on healthy aging
2. Russian and US veterinarians collaborate to solve mysterious wild tiger deaths
3. Cleveland researchers collaborate to launch Phase 1 clinical trial for new MS treatment
4. GNS Healthcare Collaborates with NCI in New Approach to Lung Cancer; Supercomputer Analysis to Aid in Matching Targeted Drugs to Patients
5. Elsevier collaborates with the Wilderness Medicine Society to award outstanding members
6. GNS Healthcare Collaborates with NCI in New Approach to Lung Cancer; Supercomputer Analysis to Aid in Matching Targeted Drugs to Patients
7. Childrens Hospital of Philadelphia collaborates in gene therapy success in an immune disorder
8. UCLAs CNSI, Dutch institute sign agreement to collaborate on nanoscience, nanotechnology
9. UCLA, Japanese company to collaborate on specialized nano-imaging instrumentation
10. SRNL, Chernobyl Laboratory collaborate on research initiatives
11. EPA and other federal agencies collaborate to improve chemical screening
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/6/2017)... 2017  SomaLogic announced today that it has ... by iCarbonX, the China -based ... Digital Health Ecosystem that can define each person,s ... biological, behavioral and psychological data, the Internet and ... SomaLogic will provide proteomics data and applications expertise ...
(Date:1/3/2017)... VEGAS , Jan. 3, 2017 Onitor, ... the introduction of Onitor Track, an innovative biometric data-driven ... men, showcasing this month at the 2017 Consumer Electronics ... In the U.S., the World Health ... more than two-thirds of adults who are overweight or ...
(Date:12/20/2016)... 2016   Valencell , the leading innovator ... STMicroelectronics (NYSE: STM), a global semiconductor leader serving ... today the launch of a new, highly accurate ... includes ST,s compact SensorTile turnkey multi-sensor ... sensor system. Together, SensorTile and Benchmark deliver the ...
Breaking Biology News(10 mins):
(Date:1/11/2017)... Angeles, California (PRWEB) , ... January 11, 2017 ... ... approach to support fertility specialists with accurate and reliable preimplantation genetic screening (PGS). ... we have achieved excellent results,” says Ovation Fertility Genetics Scientific Director Amy ...
(Date:1/11/2017)... 11, 2017  Brian Mehling, M.D., world-renowned stem cell ... Horizon International (BHI), will be attending the 47th Annual ... from January 17-20, 2017. This will be Dr. ... The theme of this year,s forum is Responsive and ... will address strategies for fostering greater social inclusion and ...
(Date:1/11/2017)... , ... January 11, 2017 , ... ... scientific grants to ground-breaking microbiome studies. Its most recent microbiome impact grant award ... who will study the effect of long-term use of oral antibiotics, prescribed for ...
(Date:1/11/2017)... ... January 11, 2017 , ... Symbios ... today that the National Science Foundation (NSF) has awarded Symbios a Small ... be used to commercialize the Symbios Tubular Plasma Reactor™ (TPR™) by scaling the ...
Breaking Biology Technology: