I expect FDA's review times will come down. How much, remains to be seen. As far as I can tell, FDA has had virtually no resources to allocate to the review of De novo petitions, because it had no real budget for them, including no budget to train reviewers, who almost certainly had little to no experience with these types of applications, given that, through 2010, CDRH had granted only 55 De novo petitions in its entire history.
I spoke with someone at FDA who was very involved with the De novo program, and who hoped they could bring FDA's timeframes down in line with 510(k)s. I'm doubtful this is realistic, especially given that the De novo review is really two reviews, one for safety and effectiveness, and the other for classification.
It is also useful to remember that the figures I've presented are from receipt to submission, which means they include both FDA's time to review the petition and the applicant's time to address deficiencies. Most likely, the companies that submitted these petitions had never submitted one before, either. I would anticipate that industry will also get better at this, and that this will also contribute to reduced overall timeframes.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 19-Jan-2018 09:13
From: Ginger Glaser
Subject: De Novo Update
Even if these numbers continue (and FDA would argue they will come down now that there are user fees and MDUFA targets) I can see why people would go this route if they expect to be evolving the device at a fast rate after launch. The 3 months difference in review time between a new 510(k) and a PMAS can be significant over a large number of changes. This is particularly true if you don't need to "competitive bar" that a PMA provides - say if your market is large enough that competitors will find entry lucrative, PMA or not. Given that whether to push down the De Novo vs PMA path often boils down to a business decision, I can see reasons to do either.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 18-Jan-2018 13:55
From: Vidyalakshmi Jayaraman
Subject: De Novo Update
Those are some interesting numbers. Thanks for the update Julie. Honestly, I'm not even sure why people use de novo, considering how long it takes, its low approval rate and the huge leap in user fees for this pathway!
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Vidyalakshmi Jayaraman
Marlborough MA
United States
Original Message:
Sent: 16-Jan-2018 01:56
From: Julie Omohundro
Subject: De Novo Update
I've been doing some more number crunching with the data in the De novo database, and thought I'd share...
This update includes the 34 "direct" De novo petitions that were submitted to the Office of Device Evaluation between August 14, 2014, and December 31, 2016, and which had been granted by December 31, 2017. Additional De novo petitions submitted during this period may yet be granted.
The average time from initial receipt to decision was 382 days, with a range of 89 to 620 days. By comparison, the time from receipt to decision for 510(k)s cleared and PMAs approved by ODE in 2016 was 158 and 508 days, respectively.
About 40% of the De novo petitions submitted during this period had been granted; the rest were presumably still under review, denied, or withdrawn.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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