FDA Announces CDRH Medical Device Innovation Initiative
MedSun: Newsletter #5, June 2006

The Food and Drug Administration (FDA) has responded to the accelerating pace of medical invention with announcement of the Center for Devices and Radiological Health (CDRH) Medical Device Innovation Initiative. Over the next decade, medical technology innovations will fundamentally transform the health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered. The CDRH Initiative follows the FDA goal of protecting and promoting public health by working to ensure timely access to safe and effective innovative medical devices.

The Initiative includes three major areas of concentration: (1) promoting scientific innovation in product development, (2) focusing device research on cutting-edge science, and (3) modernizing review of innovative devices. CDRH intends to provide regulatory clarity by releasing guidance documents for innovative products, which will not only help guide developers of specific products but will also serve as templates for similar products in the pipeline. In collaboration with industry, the clinical community, and health research foundations, CDRH is modernizing the science for developing and evaluating new medical devices, particularly for areas of unmet clinical needs such as pediatrics. The agency is focusing as well on expanding and improving communications with its stakeholder groups, including updating its device recall procedures.

CDRH scientists are addressing challenging scientific issues that arise in considering new medical device technologies. Among these is the development of new models and methods for assessing computer-assisted diagnostic systems, which has greatly aided developers of these innovative imaging and CAD-assist devices. Laboratory staff involvement can help reduce the cost and time required to demonstrate the safety and effectiveness of new innovative technologies, thereby fostering their development and speeding patient access to these products.

In modernizing the review of innovative devices, CDRH has instituted an ongoing quality review program for premarket submissions that evaluates the quality of the agency’s scientific review in several key scientific areas. It has recently completed its first round of quality reviews in biocompatibility, sterilization, and statistical analysis, crosscutting areas that are common to many medical device submissions, and has developed milestones and improved management and oversight for the review of premarket submissions. Crosscutting and process-oriented guidances, which should facilitate and improve the consistency of the review process, are also being developed.

CDRH is undertaking a number of initiatives that leverage the use of modern information technology to improve patient safety and make the development process more efficient. In addition, the agency is using the resources made available through the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) to expand its access to outside experts with current knowledge of the latest technological and clinical advances.

Additional Information:

The complete text of the FDA announcement is available at:

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