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.
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President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.
Differences between Senate and House Committee versions of the FDA Reauthorization Act passed in May and June to approve five-year device user-fee agreements have been smoothed over by committee staff and joined together in the latest version of the act. The bill has been placed on the House's calendar in anticipation of July 12 action to debate and approve the bill. Next steps in the Senate, meanwhile, remain to be seen.