Home > Newsletters > Devices & Diagnostics Letter > MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely
Devices & Diagnostics Letter
May 14, 2012 | Vol. 39 No. 20
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely
An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.