Findings From Largest Industry Assessment of 510(k) Process to be Released on May 24, 2011

What: Investigators from Northwestern University will release a new, in-depth analysis of FDA's 510(k) regulatory pathway--through which more than 90% of medical devices receive clearance--and of industry's practices within it. The study is the most comprehensive survey to date about the 510(k) process.

FDA's Center for Devices and Radiological Health (CDRH) is currently weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States. The agency has also commissioned the Institute of Medicine (IOM) to produce an independent review panel report, which will be released this summer.

The Northwestern findings—based on survey responses from more than 350 medtech product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals—are expected to help identify key opportunities for improving FDA's product review process.

The survey is part of "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform," a study funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

Who: Survey findings will be presented by investigators John H. Linehan, PhD, professor of biomedical engineering at Northwestern University, and Jan B. Pietzsch, PhD, president and CEO of Wing Tech Inc., a technology consultancy, and a consulting associate professor in Stanford University's Department of Management Science and Engineering, and the Biodesign Program.

Robert J. Rubin, MD, clinical professor of medicine at Georgetown University and chair of InHealth's Research Council, will moderate a respondents' panel comprising Susan Alpert, MD, PhD, recently retired senior vice president and chief regulatory officer at Medtronic; Peter Barton Hutt, senior counsel at Covington & Burling LLP, author of the Medical Device Amendments of 1976; and Philip J. Phillips, president of Phillips Consulting Group LLC and former deputy director for science and regulatory policy in the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. Senior leadership from FDA has been invited to participate.

Where: Zenger Room, The National Press Club, 529 14th Street NW, Washington, DC

The news conference will be broadcast live via the web.

When: Tuesday, May 24, 8:30 a.m. to 10:30 a.m.
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