FDA to Approve Innovative Medical Devices in Half the Time
FDA Introduces Medical Device Innovation Initiative (HealthPointCapital)
The FDA proposes the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced that the first submission will be a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly. The FDA will host a public meeting on March 15th.