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

This article was originally published in The Gray Sheet

Executive Summary

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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Regulatory News In Brief

FDA proposes reclassification of three devices. Group calls for release of all clinical trial data. More regulatory news.

FDA Subject To More Oversight Following User Fee Bill Passage

The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.

On Eve Of User Fee Reform, Some Minnesota Firms Signal Skepticism

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.

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