510(k) Survey Results

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.

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).
 
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.

Investigators   

John H. Linehan, PhD 
Principal Investigator
Professor of Biomedical Engineering
Northwestern University

Jan B. Pietzsch, PhD
President and CEO, Wing Tech Inc.
Consulting Associate Professor of Management Science and Engineering
Stanford University

  
Respondents' Panel

Moderator: Robert J. Rubin, MD
Clinical Professor of Medicine, Georgetown University
Member, InHealth Board of Directors
Chair, InHealth Research Council

Susan Alpert, MD, PhD
Former Senior Vice President and Chief Regulatory Officer
Medtronic Inc. 

Peter Barton Hutt
Senior Counsel
Covington & Burling LLP 

Philip J. Phillips
President
Phillips Consulting Group LLC 

Jeffrey E. Shuren, MD, JD
Director
FDA Center for Devices and Radiological Health

Event Information 

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, ygule@inhealth.org, (202) 783-0947

Media Contacts: Robyn Stein,  robyn.stein@gabbe.com;  Caitlin Hool, caitlin.hool@gabbe.com; gabbegroup, (212) 220-4444   

Download the slides for the presentation [PDF].

For more information about the survey, visit www.510k.net