Jul. 2 at 12:54 PM
$RDGL The "Day 30" Rule: The statutory calendar clock for an IDE review runs for 30 consecutive calendar days from receipt (June 5). It does not stop for mid-review holidays or weekends. Friday, July 3rd is only Day 28 of your review cycle.Only the End Date Shifts: The federal weekend/holiday rule only applies if the final deadline (Day 30) lands on a non-working day. Because Day 30 is Sunday, July 5th, the deadline rolls over to the next business day, which is Monday, July 6.The FDA's Action Window: Practically, because the FDA is closed Friday through Sunday, reviewers must issue their decision (Approval, Conditional Approval, or Disapproval) and send the email notification by the end of the day on Monday, July 6.