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House Passes Compromise User Fee Bill; Senate To Vote This Week

The final bill includes device user fee reauthorization and additional FDA reforms, including a streamlined device reclassification process that has some in the device industry nervous.

Final FDA user fee and reform legislation has cleared the House and is set for a Senate vote this week. The legislation incorporates a mix of device provisions drawn from separately passed House and Senate FDA bills, including somewhat controversial language streamlining the device reclassification process.

The compromise bill was the result of weeks of informal meetings between Senate and House staffers to come to agreement...

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