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

Rep. Ryan Costello, R-Pa., and Scott Peters, D-Calif., recently introduced legislation clarifying that the US FDA device center, rather than the drug center, will have primary authority to consider and clear new indications for imaging devices and technologies that use previously approved contrast agents.

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...

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