It’s been two years since FDA published its draft “direct to De novo” guidance, on August 14, 2014. Although many of the classification requests that have been submitted since that date are still under review, this seems like a good time to take a preliminary look at the De novos that have been granted.

Premarket submissions are not posted to FDA’s website until the review is complete, so the information provided here reflects only those De novo requests that were submitted after the draft guidance was published and had been granted as of last Friday.

Industry has made moderate use of the new De novo classification path in the two years since the draft guidance was published. It appears that some 40 De novo classification requests were submitted post-guidance. Of these, 25 had been granted by August 14, 2016. The Reclassification Orders and Decision Summaries have been posted for most, but not all, of these 25 De novo classifications.

The class of one recently classified cardiovascular device has not yet been posted. Of the other 24 classified devices, FDA determined that all but one was Class II; the remaining device was determined to be Class I.

The sample size is still too small and variability too high to draw any firm conclusions about “typical” timeframes and data requirements for De novo requests. For the 25 De novo requests that were submitted and granted in the two years after the guidance was finalized, the time between submission and reclassification ranged from 40 to 587 days, with an average of 282 days. By comparison, the average timeframe from receipt to decision for an approximately matched set of 39 510(k)s and for the 74 original PMAs approved during the same time period was 150 and 465 days, respectively.

I’m now working on a summary of the clinical data that were included in these requests and will post it soon….

source: https://www.linkedin.com/groups/78665/78665-6170959421204684803