WASHINGTON — B&D; Consulting's Vince Ventimiglia led an expert panel discussion on the FDA's 510(k) review process at the annual AdvaMed 2010 conference recently. The panel, entitled "Future of the 510(k) Review Process," was the most widely-attended session offered during the three-day international conference in Washington, D.C.

Ventimiglia addressed FDA's intention to reform the 510(k) process, a streamlined pathway to U.S. marketing clearance for certain medical devices. He and other panelists — including Susan Alpert, Ph.D., M.D. (Medtronic, Inc.), Keith Flanagan (U.S. Senate HELP Committee), Christy Foreman (Office of Device Evaluation at FDA) and Phil Phillips (Phillips Consulting) — discussed proposed agency changes in the role of "predicate devices," proposals to change the definitions of "intended use" and "indications for use," and other reforms, some of which would have a dramatic impact on patients and innovation.

Ventimiglia is currently working closely with a number clients to develop and advocate for specific, responsible reforms to the 510(k) review process that promote patient safety and public health; foster continued innovation and access to life-enhancing medical technologies; and enable product reviews in a reasonable, predictable, timely and responsive manner. Ralph F. Hall and Jennifer Nieto Carey, both of B&D; Consulting, also participate in these efforts.

Ventimiglia was selected to lead the discussion because of his extensive experience in FDA regulatory affairs. Prior to joining B&D; Consulting, Ventimiglia served as Assistant Secretary for Legislation at the U.S. Department of Health and Human Services (HHS). He had previously served as Health Policy Director for the U.S. Senate HELP Committee and as Policy Director for the U.S. Senate Budget Committee. Ventimiglia's professional background also includes extensive industry and nonprofit experience, including serving as director of government affairs at Medtronic, Inc., one of the world’s leading medical technology companies.

Hall, an advisor at B&D; Consulting and counsel with Baker & Daniels LLP, is an expert in FDA regulatory issues and counsels clients in the area of drug and medical device regulation. Hall is also a Distinguished Professor and Practitioner at the University of Minnesota Law School; Visiting Professor of Law at Indiana University School of Law – Indianapolis; and CEO of MR3 Medical LLC, a start-up medical device company based in North Oaks, Minnesota. On November 5, 2010, Hall will participate in a panel discussion on the 510(k) review process and event jointly hosted by Brookings and the American Enterprise Institute (AEI).

Prior to joining B&D; Consulting as Assistant Vice President, Carey served as health policy advisor to U.S. Representative Anna G. Eshoo of California, a senior member of the U.S. House Energy and Commerce Committee. She advised the Congresswoman on all policy issues under the jurisdiction of the Health Subcommittee, including provisions in the FDA Amendments Act of 2007 (P.L. 110-85) related to the testing of drugs and biologics used in children and medical device regulation and user fees.

ABOUT 510(k) REFORM

FDA's 510(k) review process is the route by which thousands of new medical products reach the U.S. market each year. This "pre-market notification" process allows a more rapid review of moderate-risk medical devices that are considered "substantially equivalent" to devices already cleared and legally marketed in the U.S. In response to concerns about the 510(k) process, FDA's Center for Device and Radiological Health (CDRH) conducted a lengthy internal evaluation of the process and released its preliminary internal evaluations and recommendations for reforming the 510(k) review process in August. While several of the proposed changes could be considered non-controversial consensus changes, others go beyond mere administrative or guidance changes and will require more deliberation, full Administrative Procedure Act rulemaking and even statutory changes before they can be implemented. Comments in response to the Agency's proposals were due October 4, 2010, although the agency continues to accept input. 

ABOUT B&D; CONSULTING

B&D; Consulting is a national advisory and advocacy firm based in Washington, D.C. since 1985. The firm's professionals serve clients across key sectors, advancing their objectives within increasingly complex policy environments. Whether developing a business or advancing a mission, the B&D; Consulting team has the multi-faceted skills to help clients succeed. B&D; Consulting is a division of Baker & Daniels LLP, an international law firm with offices in Indiana, Chicago, Washington, D.C. and Beijing. For more information about B&D; Consulting or Baker & Daniels, visit www.bakerdconsulting.com or www.bakerdaniels.com.