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Compliance In Focus


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Posted by John Lehmann on Fri, Jun 12, 2015

New House Bill Could Reduce 510(k) Submissions

On May 21st the House Energy and Commerce committee unanimously passed a bill that would allow medical device companies to bypass 510(k) submissions for certain product modifications.  The 21st Century Cures bill will now move to the House floor, and bill sponsors hope for a vote by the end of the year.

The device “third-party quality system assessment section” was revised by the committee and would let companies make a device modification that would typically require a 30-day notice of a “special” PMS supplement could without a submission by having their quality system specially certified by a third-party auditor.

Topics: FDA, 510(k), House of Representatives, 21st Century Cures Bill

Posted by John Lehmann on Wed, Mar 04, 2015

Medical Device User Fee Act- Full Steam Ahead!

The votes are in! The FDA Reform Act (FDARA) was strongly supported by the House of Representatives in their recent vote. We’ve been following the progress of the act, as it’s a hot topic in our industry.

Topics: The FDA Reform Act, The Medical Device User Fee Act Reauthorization, House of Representatives

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