RE:RE:RE:RE:Regarding the 2 questions of the FDA Hi all, Interesting and worrying, that LL answers you with such precise information without disclosing this publicly. This is privilege information, The FDA 510(k) process is very clear and counting the review days giving you a good window for an answer from the FDA,
If they sent the additional information package to the FDA befining of August they have received another set of questions on their answers. The FDA might have stop their clock because they live on a 30 days to provide a positive answer or repudition letter. Now it's all about how many days remain to OPS (180 days to reply to the FDA all questions). My assumption is that they are at the second rounds of questions and they might have Safety questions to still answer from their in human validation (DATA collecton/study deisgn and/or Primary measure) was partially adressed in their report and FDA is asking them to provide additional evidence ( the most probable reason why they didn't reply before August) (I've not made my research but this is publicly available (enrolling) on Clinicaltrial.gov) If the Study is still open it will be mentioned there.
By experience, When FDA received a Addionnal Info package they usually turn it back in 4-5 calendar days in contrario with the first review of the package who takes usually 15-18 days. (than based on my calculation FDA still have less than 5 days in bank for their review (second AI package) Usually the last 2 days are used to review IFUs and 510k summary and producing clearance letters. FDA usually goes throught the entire 30 days. They don't have the right to mistake. And believe me they are professional, they don't cut corners.
At this moment I do not believe that they are not in an interactive review with the OPS team. because, by default such process is usually a good thing and goes fast, Interactive review are quick additional information to be answer by the Inc without additional evidence to be officially sent to the FDA, it could be handle via emails or by phone with their Lead FDA reviewer. And moreover using that pathway doesn't stop the FDA clock. then OPS team are under pressure since their 180 days is melting every days.
Best of Luck to the OPS team your product is absolutly a gold standards. The next 2-3 weeks are, in my humble opinion, the most critical for this project and submission. Since they filed their 510k last March , they are close to the end. Let's hope that they gonna get a clearance from the FDA.
by mid september, Let me guess the 13