AIMBE was one of the first organizations to partner with the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) to sign a Network of Experts Agreement.
The CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In order to better meet this responsibility, the CDRH identified a need for additional medical and engineering expertise from the broader scientific and engineering community to enhance the knowledge base of their own staff. Through the Network of Experts Agreement, AIMBE’s College of Fellows—around 1000 innovators and pioneers from the medical and biological engineering community—will be called to provide scientific and engineering knowledge to the CDRH at the FDA’s discretion. This will provide the FDA with access to leading engineers in new and emerging technologies in bioengineering to better fulfill their mission.
By partnering with the CDRH, AIMBE is committing to providing access to the College of Fellows whenever an expert is needed. Through this collaboration, AIMBE continues to demonstrate its role as a major thought-leader in medical and biological engineering.
Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological released this statement: “Rapid access to the expertise of AIMBE’s distinguished College of Fellows will help to broaden CDRH’s scientific viewpoints and assure that we consider the most current information on emerging fields of science and pioneering biomedical technologies related to medical devices.”
AIMBE is proud to be providing access to our College of Fellows, comprised of the most cutting-edge and pioneering leaders of biomedical engineering, to the CDRH at the FDA. Our mission includes building strong relationships with government agencies in order to advance the potential for medical and biological engineering to improve our quality of life, and this Network of Experts Agreement contributes greatly to that goal. We consider this a new opportunity for public service leveraging the considerable scientific and medical knowledge of AIMBE Fellows to benefit all Americans.