Navigation Links
FDA Fireside Chat @ The 8th Annual MedTech Investing Conference May 6-7, 2009

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

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:

About IBF*International Business Forum, Inc.

IBF*International Business Forum, Inc. is a leading presenter of venture capital, technology innovation and private equity conferences in the United States. For 20 years, IBF has been presenting conferences which unite investors, emerging growth companies and corporations. IBF produces conferences on the following venture capital subjects: Venture Capital Investing, Early Stage Investing, Cleantech Investing, Corporate Venturing & Strategic Partnering, Biotech & Life Sciences Investing, Medical Devices and Healthcare Technologies Investing, Consumer Medicine, Tech Transfer Investing, and Nanotechnology Investing. To see a full listing of IBF's conferences please visit:

SOURCE International Business Forum, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. John Wayne Cancer Institute Auxiliary Honors Award-Winning Actress Bonnie Hunt and Philanthropists Donna & Harvey Rosen at the 24th Annual Odyssey Ball
2. Cowden Associates Releases Eighth-Annual Employee Benefit Survey Results
3. Dr. William Bill Braithwaite and Dr. John Macaulay Present Anakams Two-Factor Authentication Platform at HIMSS 2009 Annual Conference and Exhibition
4. Home Care Delivered, Inc. Recognizes 21st Annual American Diabetes Alert Day
5. Meningitis Angels to Support First Annual World Meningitis Day
6. LLE to Sponsor 16th Annual Tri-State Telecommunicators Banquet and Awards Ceremony
7. Annual Keenan Summit Addresses Challenges and Opportunities in Health Care
8. VNUS Medical Technologies to Present at the Sidoti & Company 13th Annual New York Emerging Growth Institutional Investor Forum
9. American TeleCare to Present its Wireless Wide Area Network (WWAN) Option for Cellular Telehealth Connectivity at the American Telemedicine Association (ATA) Annual Meeting
10. US trial shows no early mortality benefit from annual prostate cancer screening
11. Bionovo to Present at Wall Street Analyst Forums 20th Annual Institutional Investor Conference
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced a special promotion ... off of their purchase of lice treatment product. In addition, customers will receive a ... company spokesperson. “Finding lice is a sure way to ruin the holidays, so we ...
(Date:11/27/2015)... Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... for use in Final Cut Pro X. With ProSidebar: Fasion, video editors can ... or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop ...
(Date:11/27/2015)... ... 2015 , ... Consistent with the Radiology Business Management ... Radiology Marketing Programs meeting will showcase some of the best 2015 radiology ... Palace in Las Vegas with a pre-conference session on a collaborative approach for ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, ... interesting show that delves into an array of issues that are presently affecting Americans. ... from open dialogue, this show is changing the subjects consumers focus on, one episode ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... Health-E-minds, an innovative online platform for mental health and wellness consultation, has collaborated ... This partnership will bridge the knowledge gap experienced by parents and bring advice ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Italian therapeutic drug monitoring market, including emerging ...
(Date:11/25/2015)...  Amgen (NASDAQ: AMGN ) today announced the ... the United States (U.S.) Food and ... to Humira ® (adalimumab). Amgen believes this submission ... FDA and represents Amgen,s first BLA submission using the ... M.D., executive vice president of Research and Development at ...
(Date:11/25/2015)... Nov. 25, 2015  ARKRAY USA ... to provide evidence demonstrating the accuracy of its blood ... on Insulin Resistance, Diabetes and Cardiovascular Disease in ... the Company,s GLUCOCARD ® 01 meter and the ... requirements. The ability to accurately measure glucose levels in ...
Breaking Medicine Technology: