Senate Bill Would Streamline FDA's New Device Reviews
Sens. Bob Casey, D-Pa., and John McCain, R-Ariz., said their bill would streamline the regulatory review process for brand-new medical devices that aren't similar to any existing devices.
Under the Safe, Efficient and Transparent Medical Device Approval Act, manufacturers with such new devices would be able to skip the 510(k) process, which the senators said was...
To view the full article, register now.