Senate Plans FDA User Fee Markup This Week; House Not Far Behind
This article was originally published in The Gray Sheet
Updated draft user fee reauthorization bills issued last week reflect works in progress as lawmakers aim to reach consensus on FDA reforms.
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Bipartisan FDA user fee reauthorization and reform legislation sailed unanimously through the House Energy and Commerce Committee May 10, with many similarities to a Senate version that has also passed out of committee.
Legislation was reported out of committee last week, with some additional amendments under consideration as the user fee reauthorization bill moves closer to the Senate floor. House members still struggle to reach consensus.
Center Director Jeffrey Shuren says it was not CDRH’s intention to force more 510(k)s for device modifications with its July 2011 draft guidance. The center plans to take the unusual step of issuing a revised draft to respond to industry complaints.