RE: Daedlines28 Jul 2022 19:23
Thank you, Vanilla
I did listen to the interview with interest. I own two businesses. One makes laboratory equipment for use in the R&D/drug discovery end of the pharma business and the other is a consultancy that project manages complex IVD and medical device product developments, including generating all of the documentation needed for 510k, CE and NMPA (that’s Chinese FDA) registrations. And management of the registration process. So, I’ve got lots of real world experience with what AVO are trying to do.
I’d be very wary of the 90 day period. Actually, when you get into it, the 90 days is days of FDA review time. With a total allowable period of 180 days before a submission needs to either be approved or resubmitted. What does this mean? Well, when you get into the practicalities of 510k submissions, the FDA will often review a submission so far, come up with questions and then put your submission on hold (stop their 90 day clock) whilst they let you go off and work on a reply.they can also be sneaky and do this when they are very busy, trying to juggle their 510k commitments - not how they should behave, but it absolutely happens. Then, when you respond, restart their 90 day clock. This means that submissions can actually take as long as 180 days (yes, I’ve been there) and based upon my experience I think 90 days straight without the FDA using submission hold time for something new like this would be very unusual.
Being prudent, I’d go with this being 90 minimum, plus some amount to account for submission hold, dealing with questions that require responses from AVO that take time to respond to (these could include a request for AVO to do actual work). I’d thus say the window you are looking at is somewhere in the range 90-180 days, but hopefully nearer the 90 day end of the scale.
The bottom line is the 510k review process can be an exciting ride and highly challenging to predict the overall timeline precisely. I’ve seen sensor company executives almost bought to tears when their 510k is not going as expected, along a longer timeline path and all of the pressures and uncertainty that can create.
Bill