This should answer everyone's questions on this:
FDA’s Revised Guidance Provides Update on Direct De Novo Pathway
Published October 9, 2014
By Yarmela Pavlovic and Gerry Prud'homme
The U.S. Food and Drug Administration (FDA) recently released a revised guidance document addressing the de novo premarket review pathway for medical devices. The draft guidance, titled “De Novo Classification Process (Evaluation of Automatic Class III Designation),” updates an earlier draft released in 2011 and seeks to implement changes to the de novo process required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
Timeline for Review
The FDA has a total of 120 days to complete its review of the submission, though the agency may stop its review clock by requesting additional information from the submitter at any time. Typically this occurs at approximately 60 days and multiple, iterative requests for additional information have been common in the past with these submissions. Further, while the nominal total review timeline is 120 days, this timeline has not uncommonly been exceeded in recent direct de novo applications.
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