The deadline, shown as a calculation
A countdown tells you a date. Eight months later, somebody wants to know how that date was reached - which day counted as Day 0, who decided that, and which days were excluded.
Day 0 is not the day you noticed
It is the day the information reached your company. If a message sat unread in a shared inbox over a weekend, Day 0 was before anyone opened it.
So confirming Day 0 requires four things, and the software will not record it with any of them missing:
- The date
- A named person who confirmed it - not the software, and not an account shared by the whole company
- The reason - what evidence supports that date
- The evidence itself, attached to the case
Six criteria, assessed separately
Seriousness is not one judgement. Each criterion is considered on its own, by a named reviewer, and the record shows which were met and on what basis.
- Death
- Life-threatening experience
- Inpatient hospitalisation
- Persistent or significant disability or incapacity
- Congenital anomaly or birth defect
- An intervention required to prevent one of the above
The software never makes this determination. It lays out the criteria, records what a person decided, and shows who and when. That is a design decision, not a feature waiting to be added, and it will not change on any plan or in any version.
What the calculation records
Every deadline keeps its own inputs: Day 0, who confirmed it and why, the business calendar and its version, every excluded day with the reason, and the resulting due date.
Why the calendar version. If your holiday list changes next year, this calculation must not change with it. A deadline calculated under the 2026 calendar keeps the 2026 calendar for ever, so a past case is never silently recalculated.
The clock does not pause
Waiting for a reporter to reply is the common way a deadline is missed. Follow-up requests, each attempt, and every non-response are recorded - and the case is still assessed with what is known. Submitting with incomplete information and following up afterwards is normal and expected.
This describes how the rules generally work. It is not legal or regulatory advice, and whether a specific event is reportable is a judgement for a qualified person who knows your facts. The app prepares Form 3500A content and records the submission you make - it does not file anything with FDA.
See it on a real case
Ten steps, about four minutes, no signup. All data fictional.