Compliance In Focus

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 The communications are outlined in the MDUFA III Commitment Letter and are further described in the draft guidance released on March 5, 2013 titled Types of Communication During the Medical Device Submissions.

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