And then again the timeline could be much shorter? Does the clock start running on the 90 day period. from 1 the beginning OR since we had already been accepted for substantive review accelerate the time period? Personally IMO it will be shorter!
Hey GR$. Nice article. However it was focused on a range (qfm/ qih) of products that have little in common with Hemostyp. That being said it does shed a little light on timelines. You should always read for what is real and not just what you want to interpret. Fake DR5 wouldn’t look for reality so he is a very poor reference. Like with all dr5 diagnosis you should always ask for a second opinion.
Here’s the articles concluding statement:
Conclusion
So there we have it - it takes on average between 154 (for QFM) to 201 (for QIH) total days to receive a 510(k) decision for SaMD products,