Obviously More DD is Needed Regarding the 510k Process
Day 7 - Acknowledgement Letter from FDA
Day 15 - Acceptance Review, FDA is continuing with review or explanation of why the review can not proceed
Day 60 - Substantive Review, FDA is continuing with review or has been placed on hold until further information has been submitted.
Day 90 - FDA notifies submitter of their decision
Day 100 - If 90 Day decision is missed FDA will communicate outstanding review issues
BIEL submitted their 510k on 7/12/2018. In AW's Uptick Interview, which was released on 9/11/2018 but recorded several days earlier, he stated there had been no additional information requests from the FDA.
We learned through various sources that there had been additional information requested at the 60 Day Review. This stopped the FDA clock.
BIEL supplied the requested information to the FDA approximately 3 weeks after their request. I have not seen any reliable source state the exact date the information was supplied.
The information available indicates that we need to add 21 days to the FDA 90 day clock as it was stopped while BIEL prepared their response to the FDA's questions.
We are currently at day 109 since submission. If the three week hold is correct the adjusted 90 days would occur on 10/31/2018. Of course the FDA could miss their 90 Day goal or the 3 week estimate could be off by a couple of days, up or down.
"510(k) Decision Letter The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request."
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