CDRH head Jeffrey Shuren warned Tuesday the U.S. faces a "perfect storm" of challenges that threaten its global leadership position in medical technology. A weak economy, changing science and red tape could thwart approval and payment of new products. However, Shuren assured attendees of the University of Minnesota's annual Design of Medical Devices conference that the FDA is ready to help innovative businesses.
Shuren also addressed topics that have been discussed before--such as the creation of a Center Science Council to oversee clinical studies--but, as the Minneapolis Star Tribune points out, his discussion comes as Congress readies itself for hearings on how the FDA approves medical devices.
Today, the Senate Special Committee on Aging will hold a hearing titled "A Delicate Balance: FDA and the Reform of the Medical Device Process." And Shuren himself will appear Thursday before the House Oversight & Government Reform Subcommittee on Health Care in a hearing called, "Pathway to FDA Medical Device Approval: Is There a Better Way?" Rep. Erik Paulsen (R-MN), Jack Lasersohn, general partner, The Vertical Group, and David Gollaher, president and CEO, California Healthcare Institute, also are slated to appear.
- see the CHI release
- get more from the Star Tribune