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FDA Fireside Chat @ The 8th Annual MedTech Investing Conference May 6-7, 2009
Date:3/26/2009

f 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 (O
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