The recently-enacted Food and Drug Administration Reauthorization Act (“FDARA”) includes the Medical Device User Fee Amendments of 2017 (“MDUFA IV”) (see our summary here). This new law affects multiple aspects of the device review process. MDUFA IV supplements FDA’s funding of device regulation, with the goal of increasing the speed and efficiency of the Agency’s review of new devices, as well as improving the safety and effectiveness of marketed devices. In addition to modifying the user fees, MDUFA IV broadens the scope of submission subject to user fees and performance goals.
Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be moderating the Food and Drug Law Institute’s (“FDLI’s”) November 30, 2017 webinar, titled “MDUFA IV and Related CDRH Guidance Documents: Impacts on Industry.” Webinar panelists will discuss relevant aspects of FDARA and the MDUFA IV Commitment Letter, highlight major changes to the program, and discuss the effects on the device industry, including the issuance of substantive key new guidance documents, such as when new 510(k)s must be submitted.
Additional information on the FDLI webinar, including registration information, is available on FDLI’s website here.