Regulatory Open Forum

Has anyone had experience filling a Direct De Novo request?  I'd appreciate hearing about your experiences and input about this.

Thanks in advance!

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Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States
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Hi Patrick -

I have helped several companies with Direct De Novo requests. Overall I have found the experience to be positive. Most of these submissions were done prior to the updated MDUFA fees and timelines; so these submissions had no associated user fee, but also no MDUFA timeline goal. Due to the lack of a timeline goal, the review was a little unpredictable. One of these submissions did not receive any substantive feedback or questions until day 180 or so; needless to say this was a longer review than anticipated.  Recently, the new MDUFA fee and timeline have helped in this regard, with FDA providing feedback in a more timely fashion. I would recommend a pre-submission with FDA to discuss if the De Novo pathway is appropriate and if the proposed test plan seems acceptable. We have had success going this route with several different devices and would recommend this approach if the device fits the De novo criteria. 

Happy to answer any additional questions. Hope this helps!

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Samuel Pollard
Senior Associate, Regulatory Affairs
Washington DC
United States
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Original Message:
Sent: 13-Mar-2019 17:01
From: Patrick Martin
Subject: Direct De Novo Request

Has anyone had experience filling a Direct De Novo request?  I'd appreciate hearing about your experiences and input about this.

Thanks in advance!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

​Hi Patrick,

My suggestion would be to engage in a comprehensive pre-submission process as early as possible and try to achieve alignment on the clinical and analytical/bench testing required. It is also helpful to discuss desired labeling claims as early as possible. This will reduce your review time. I found that the review team responded to frequent communication during the review process and in between pre-subs, even informally. In my experience the review time was 6-7 months from submissions to de novo requests granted.
Original Message:
Sent: 14-Mar-2019 08:51
From: Samuel Pollard
Subject: Direct De Novo Request

Hi Patrick -

I have helped several companies with Direct De Novo requests. Overall I have found the experience to be positive. Most of these submissions were done prior to the updated MDUFA fees and timelines; so these submissions had no associated user fee, but also no MDUFA timeline goal. Due to the lack of a timeline goal, the review was a little unpredictable. One of these submissions did not receive any substantive feedback or questions until day 180 or so; needless to say this was a longer review than anticipated.  Recently, the new MDUFA fee and timeline have helped in this regard, with FDA providing feedback in a more timely fashion. I would recommend a pre-submission with FDA to discuss if the De Novo pathway is appropriate and if the proposed test plan seems acceptable. We have had success going this route with several different devices and would recommend this approach if the device fits the De novo criteria.

Happy to answer any additional questions. Hope this helps!

------------------------------
Samuel Pollard
Senior Associate, Regulatory Affairs
Washington DC
United States

Original Message:
Sent: 13-Mar-2019 17:01
From: Patrick Martin
Subject: Direct De Novo Request

Has anyone had experience filling a Direct De Novo request?  I'd appreciate hearing about your experiences and input about this.

Thanks in advance!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States
------------------------------