US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate

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.

[Editors' note: Follow progress with legislation impacting the device and diagnostics industry with Medtech Insight's US Congress Tracker.]

The House unanimously passed H.R. 2430, the FDA Reauthorization Act of 2017, which would reauthorize the MDUFA IV user-fee agreement for the next five years, including about $1bn in device...

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