FDA and Medical Devices Subject of Congressional Hearing
The House Oversight & Government Reform Subcommittee on Health Care is scheduled to hold its “Pathways to FDA Medical Device Approval: Is there a Better Way?” hearing tomorrow, June 2, 2011. The panel is set to call FDAs Dr. Jeffrey Shuren, Director of Centers for Devices and Radiological Health; in order to “study the FDAs inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
In addition to Shuren, the committee is set to call Congressman Erik Paulsen (R-Minn.), Jack Lasersohn of the venture capital firm The Vertical Group, Dr. David Gollaher of the California Healthcare Institute, and Dr. Rita Redberg, Director of Womens Cardiovascular Services in the Division of Cardiology at the University of California, San Francisco. Representative Paulsen is a supporter of the medical device industry and is currently pushing for legislation to “modernize” the FDA and block implementation of a $20 billion tax on medical devices. According to Paulsen, “[w]ere going to propose legislation that modernizes the FDA so that this industry remains strong. Companies dont mind if [FDA review] is rigorous. They want to make sure its relevant.”
Fuerst Ittleman recognizes the importance of a consistent pathway for FDA medical device clearance. We will monitor this and future hearings related to the FDA and changes to the medical device review process. For more information on FDAs regulatory oversight of medical devices, please contact us at contact@fidjlaw.com.