Amid much consternation about the cost and effectiveness of the FDA’s process for approving new medical devices, the industry’s trade association in Minnesota is announcing plans for a partnership with regulators to develop “regulatory science.”
Both industry and regulators are taking lots of flack these days.
The industry has been battered by deaths and injuries related to faulty products, and pilloried for consulting payments to physicians. Meanwhile, the industry has long complained the FDA’s device approval process takes too long and is too expensive.
Earlier this year a study reported in the Archives of Internal Medicine found most medical devices recalled in recent years as a result of deaths or life-threatening problems were approved under regulatory criteria that don’t require human testing. An accompanying editorial said, “millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.”
On the eve of LifeScience Alley’s Tenth Annual Conference & Expo this Wednesday, this message arrived in the inbox from Dale Wahlstrom, President & CEO of LifeScience Alley and The BioBusiness Alliance of Minnesota. Wahlstrom said he and Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health will be signing a memorandum of understanding (MOU) between their respective organizations.
The MOU is a critical step in a partnership that has been developing between LifeScience Alley and CDRH for over a year. It recognizes that CDRH and the medical technology sector represented by LifeScience Alley have shared interests in further developing regulatory science and in enhancing the understanding of the safety, effectiveness, quality, and performance of devices. This agreement builds the foundation for specific projects that will improve the environment in which the medical device industry is operating, including a more formal partnership involving MedTech community members, University of Minnesota experts, and CDRH.
Dr. Shuren will also deliver a keynote address explaining what regulatory science is and how the partnership model we are working to develop in Minnesota will impact the development, analysis and approval of medical devices.