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De Novo Applications since July 2012




I'm doing some research on De Novo submissions on Medical Devices (not IVDs) since the introduction of the July 2012 legislative amendment.

I've summarised the relevant information from the FDA website (attached). Only four medical devices submitted and approved since July 2012 so it's not really possible to see any trends in time taken etc.

Does anyone know the location of any data relating to:

  • the number of Pre De Novo Submission (PDS) that have been submitted since July 2012 and how long they are actually taking from receipt to FDA recommendation
  • The number of De Novo Petitions that have been rejected since July 2012
  • any commentary / experience folk have had with De Novo since the introduction of the amendment


I was guessing that you were aware of this page:

which is the FDA's list of de novo clearances.

I get an e-mail bulletin from FDA each day which includes notification of any new entries to that list. From that you can see the original submission year (first two digits of the k number) which gives some idea of just how long the whole process can take. I seem to recall some taking 3 or 4 years!

See k083767 and k112711 as examples.


Hi Pads

Thank for your reply. This is the site I used to gather the statistics in the attachment. It's really useful. Do you know of any sites that have similar information for the PDS'?
I just posted ODE data for direct De novos in 2018 under Other US Medical Device Regulations.

The De novo regulatons are not part of the QSR.
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