Uniting the Venture Capital Community to Drive Innovation through Investment Opportunities in the Multi-Billion Dollar Medical Device Market
MINNEAPOLIS, March 26 /PRNewswire/ -- The 510(k) program is under siege from within and outside of the FDA. Eight scientists complained in a letter to Congress that CDRH management is overruling their scientific determinations requiring more data for 510(k)s. They followed that complaint to Congress with another letter to the Obama Administration after the election. Their argument is that CDRH is clearing 510(k)s on scant data and allowing unproven medical devices to come to the market. The New York Times did a series complaining about the same issues entitled “The Evidence Gap.” Even the esteemed New England Journal of Medicine carried an article by a physician complaining about CDRH’s clearance of the fractured Medtronic Sprint Fidelis defibrillator leads based upon allegedly inadequate data. Finally, the General Accounting Office (GAO) published its report on the 510(k) program and Congress is poised to hold hearings on whether the 510(k) program should change. Miriam Provost, a former Deputy Director for Science and Engineering Review in the Office of Device Evaluation (ODE) who left the Agency in 2007, was quoted in the Grey Sheets defending the Agency stating that some scientists within the Agency simply don’t like the 510(k) program and are trying to make it something it is not. She said they attempt to “change the standards [for clearance] on an application-by-application basis.”
This session will be feature CDRH’s Don St. Pierre who has a distinguished career with CDRH starting as field engineer testing medical devices in CDRH laboratories, then he progressed to a reviewer in two divisions (Cardiovascular Devices and Reproductive, Abdominal, Ear, Nose, Throat and Radiological Devices). He has been a Branch Chief and Deputy Director of the Division of Clinical Laboratory Device and was Deputy Director for New Device Evaluation in the office of OIVD and is currently Associate Director for Policy in OIVD. Mr. St. Pierre’s education as an engineer and experience as a reviewer and manager within FDA make him well qualified to discuss what is happening within the Agency as it relates to the 510(k) program.
In this fireside chat scheduled for May 7th, FDA Legal & Regulatory expert, Mark DuVal will explore the contours of the 510(k) program and ask Mr. St. Pierre questions about whether he believes the scientific requirements are on the rise, do new employees understand and employ the substantial equivalence standard for clearance and what is CDRH doing to address these issues? Mr. St. Pierre will share his views about the 510(k) program and provide an update on political developments.
To learn more about the event and to register, visit www.medtechconference.com.
Don St. Pierre graduated with honors in 1985 with a Bachelor’s Degree in Engineering Science and Mechanics from Penn State University. He spent 3 years testing medical devices in FDA’s field engineering laboratory before coming to the Center for Devices and Radiological Health’s (CDRH’s) Office of Device Evaluation (ODE) in January 1990. At ODE, he worked in various divisions -- starting as a reviewer in the Division of Cardiovascular Devices, then moving on to the Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices as a reviewer in the Urology and Lithotripsy Devices Branch. In November 1995, he became the Branch Chief of the Urology Branch; in April 2000, he became the Deputy Director of the Division of Clinical Laboratory Devices; and in November 2002, he became the Deputy Director for New Device Evaluation in the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) and currently serves as the Associate Director for Policy and Operations in OIVD.
Mark E. DuVal, is President of DuVal & Associates, where he counsels both mature and venture-backed pharmaceutical, medical device, and biotech companies in the United States and Europe in addition to working extensively with combination products. DuVal regularly advises clients in all areas of FDA law and regulation, from product development, clinical trials, inspections and recalls to reimbursement and compliance issues and post-marketing responsibilities. He specializes in counseling medical device and pharmaceutical companies in the development and implementation of strategic and tactical sales and marketing plans that are appropriately aggressive, yet compliant.
Event Sponsors & Exhibitors Include
Oppenheimer, Wolff & Donnelly LLP, PricewaterhouseCoopers, Dorsey & Whitney LLP, Capital Advisors Group, RBC Capital Markets, Alquest, Devicix, Minnetronix and RCRI, Inc.
About LifeScience Alley(TM)
LifeScience Alley(TM) is the largest trade association serving the life sciences in the Upper Midwest. It represents more than 600 member companies, organizations and institutions of all sizes that devote their efforts to the research, development and commercialization of the life sciences. LifeScience Alley acts as the industry’s central resource for fostering innovation, offering education and creating consensus. It offers members unique opportunities to network and collaborate and provides them with a strong, unified voice at the state and federal level. Members hail from all life science industry sectors, including medical device, pharmaceutical, biopharmaceutical, health care providers and insurers, agricultural and industrial biotechnology, and renewable energy. For more information, visit: www.lifesciencealley.org
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