Arch Therapeutics Inc (ARTH)

[codaras]

Timeline of Communication during 510(k) Review

Day 1: FA receives 510(k) submission. By day 7, FDA sends acknowledgement letter or FDA sends hold letter if unresolved issues with user fee and/or eCopy. By day 15, FDA conducts acceptance review. FDA informs submitter if 510(k) is accepted for substantive review or placed on RTA hold. By day 60, fda conducts substantive review. FDA communicates via a substantive interaction to inform the submitter that the FDA will either proceed with interactive review or that the 510(k) will be placed on hold and additional information is required. By day 90, FDA sends final MDUFA decision on 510(k). By day 100, if MDUFA decision is not reached by day 100, FDA provides missed MDUFA decision communication that identifies outstanding review issues.

Important Notes:
•Days are Calendar Days.
•The timeline is based on the performance goals set by Medical Device User Fee Amendments of 2012 (MDUFA III).
•This timeline has been simplified.

They should already know. A P.R. of the info would be appreciated.