The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The Food & Drug Administration’s Center for Devices and Radiological Health will release its proposed changes for the 510(k) regulatory pathway for medical devices, President Barack Obama revealed today.
In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.
Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.
Shuren told MassDevice that a study by researchers at Stanford University titled “FDA Impact on U.S. Medical Technology Innovation,” which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was “highly flawed.”
