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Compliance In Focus


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Posted by John Lehmann on Wed, May 18, 2016

FDA Outlines MDUFA Proposal Cost

After several months of deliberation, the FDA has put some hard numbers to how much the proposed user fee reauthorization act (MDUFA IV) would cost. The agency has indicated the price tag of the reforms at $500 million over five years on top of the current user fee base. This does not take inflation into account.

The FDA had initially estimated it would cost and extra $456.4 million over five years. However, after more analysis the agency update the estimate according to January 27th meeting minutes.

Topics: MDUFA, FDA

Posted by Brandy Chittester on Wed, Mar 04, 2015

New FDA Guidance- Help or Hurt the Device Review Process?

In response to The Medical Device User Fee Amendments of 2012 (MDUFA III), which authorizes the FDA to collect user fees for the review of certain premarket submissions, the FDA proposed process improvements  to provide further transparency to the review process, including new communication commitments. These new communications are in the context of acceptance review, substantive interactions, and missed MDUFA goals. The communications are outlined in the MDUFA III Commitment Letter and are further described in the draft guidance released on March 5, 2013 titled Types of Communication During the Medical Device Submissions.

Topics: New FDA Guidance, MDUFA, Device Review Process

Posted by John Lehmann on Wed, Mar 04, 2015

Moving Forward: The Medical Device User Fee Act

Recently MassDevice covered the announcement that the proposed recommendations for the Medical Device User Fee Act (MDUFA) were cleared by the House Subcommittee.

Topics: MDUFA, FDA

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