News Release: Further information…"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. MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE)."