AP investigation shows thousands of unsafe devices cleared by FDA through streamlined pathway.

In a nearly 3,800-word piece, the AP (11/27) reports the FDA’s declaration it strives to be “first in the world” to approve critical medical devices “mirrored the talking points of the $400 billion medical device industry...and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.” Under Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, “annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and quality issues have fallen roughly 80 percent, an Associated Press investigation found.” According to an AP analysis of FDA data, since 2012, “tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing.” The agency on Monday “proposed changes to the streamlined system that would push manufacturers to incorporate more up-to-date technology into their devices,” but major reforms “could take years to implement.”