House Bill Clarifies CDRH Lead For New Imaging Indications For Devices Using Contrast

The US imaging equipment and contrast-agency industries are touting a recently introduced US House bill that lobby groups say would provide "a clear regulatory pathway" for imaging device manufacturers to win clearances for new indications of their products involving formerly approved contrast agents.

H.R. 2009, the "Fostering Innovation in Medical Imaging Act of 2017" was introduced April 6 by Reps. Ryan Costello, R-Pa. and Scott Peters, D-Calif., and referred to the House Energy and Commerce Committee for consideration