FDA Publishes Frequently Asked Questions Concerning the New Medical Device Registration and Listing Requirements

President Obama signed the FDA Safety and Innovation Act (FDASIA) on July 9, 2012, which requires certain changes to the registration and listing of medical devices that will take place on October 1, 2012. FDASIA includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. Ultimately MDUFA III represents an agreement and commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market. The new registration and listing changes are also part of the publication of the revised 21 C.F.R Part 807 on August 2, 2012.

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