House Passes Compromise User Fee Bill; Senate To Vote This Week
This article was originally published in The Gray Sheet
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.
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The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.
A survey of Minnesota device executives released last week closely aligns with previous industry polls, but the timing is notable: it comes just as Congress is completing passage of a user fee reauthorization bill championed by national device groups.