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Compliance In Focus


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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 The communications are outlined in the MDUFA III Commitment Letter and are further described in the draft guidance released on March 5, 2013 titled Types of Communication During the Medical Device Submissions.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

How Would You Improve FDA’s Device Review Process?

This is a question that FDA is asking the public. Recently on Federal Register, the FDA announced an opportunity for the public to comment as part of an assessment process of the medical device review/submissions.  This opportunity stems from the MDUFA Commitment Letter, where FDA has a section describing the assessment of review process management to meet certain performance goals agreed to by industry and FDA.

Topics: Device Review Process, Federal Register, FDA, 510(k)

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