Good afternoon,
The FD&C Act when revised to allow for direct to
de novo applications (as opposed to first seeking 510k to then be declined), states a 120 day review time. Very briefly, products requiring a
de novo are inherently novel and require additional considerations related to appropriately identifying "special controls" to adequately reclassify. A lot of emphasis is placed on the risk/benefit analysis to support the marketing authorization decision. Thus, 120 days is a challenge to achieve. With MDUFA IV came a commitment to a more realistic review clock and a price tag. I would encourage review of the quarterly performance reports available on FDA's website if you have not already discovered. Right now, FDA is averaging 130 days to a
de novo decision (their clock). Typically, a deficiency letter/additional info request is issued which stops the FDA clock and turns on the sponsor's clock. Sponsor time is averaging a 105 days. In total, 230 days is the average from start to finish. Please note, this is not a normal distribution and looks like there may be some significant outliers with a very long decision time pulling this average up a bit.
Hope this helps.
Best,
Danni
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Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States
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Original Message:
Sent: 10-Feb-2020 11:34
From: Anonymous Member
Subject: De Novo Review time
This message was posted by a user wishing to remain anonymous
Hello
Can someone explain this sentence :
Under the MDUFA IV, FDA has committed to completing review of De Novo requests in 150
FDA review days, with the percent of submissions required to meet this goal increasing from
50 to 70 percent over the next several years, as detailed in the table below. This is a change
from the statutorily required review timeline of 120 days.
What is the difference between the MDUFA IV review time(150 days) and statutorily review time (120days) for De Novo Application?
Thanks you