Survey Analysis to Identify Opportunities
for Improving and Strengthening
FDA's Product Clearance Process
Jeffrey E. Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health (CDRH), will participate in the Tuesday, May 24, news conference and webcast at which investigators from Northwestern University will release a new, in-depth analysis of FDA and industry practices within the 510(k) regulatory pathway. The study is the most comprehensive survey to date about the 510(k) process. The findings will be presented at a news conference at the National Press Club and streamed live on the web. Download the slides for the presentation [PDF].
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.
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
After the investigators' presentation, Shuren will share FDA's viewpoint as part of a respondents' panel, moderated by Robert J. Rubin, MD, clinical professor of medicine at Georgetown University and chair of InHealth's Research Council.
H. Linehan, PhD
Professor of Biomedical Engineering
B. Pietzsch, PhD
President and CEO, Wing Tech Inc.
Consulting Associate Professor of Management Science and Engineering
Robert J. Rubin, MD
Clinical Professor of Medicine, Georgetown University
Member, InHealth Board of Directors
Chair, InHealth Research Council
Alpert, MD, PhD
Former Senior Vice President and Chief Regulatory Officer
Covington & Burling LLP
Phillips Consulting Group LLC
E. Shuren, MD, JD
FDA Center for Devices and Radiological Health
This event is open to the public. Please contact InHealth if you plan to attend. The news conference will be broadcast live via the web at: www.inhealth.org/510ksurvey. Click the link to register any time before the event.
Where: Zenger Room, The National Press Club, 529 14th Street NW, Washington, DC.
When: Tuesday, May 24, 8:30 to 10:30 a.m. EDT
Contact: Yolanda Gule, InHealth Administrator, firstname.lastname@example.org, (202) 783-0947
For more information about the survey, visit www.510k.net