S3 · Validation done
Validation gap review
Your reports read element by element against what cleared summaries in your code state — before the FDA reads them.
- S1
Idea / early design
Regulatory pathway brief
Where does our device fit, and what has the FDA already cleared that looks like it?
- S2
Planning validation
Evidence plan
What will our validation have to show, and what should we ask the FDA before we run it?
- S3
Validation done
Validation gap review
Do our reports state what cleared devices in our code stated, and where are the gaps?
- S4
Ready to file
Submission drafting
Can the submission content be assembled without losing three weeks to tables and checklists?
The stage
Validation done: the reports are written and a filing date is set.
The question this week
“Do our reports state what cleared devices in our code stated, and where are the gaps?”
Who it is for
- Regulatory leads with a filing date and finished test reports
- Small teams without a second reader
- Consultants who want an independent check before filing
The problem
- A missing element is usually found by the FDA, as a request for additional information that costs weeks.
- Nobody has the time to cross-read every report against the code's precedent.
- It is unclear which gaps matter most in this particular code.
You send
- Your validation and performance test reports
- The device description and product code
Under a signed confidentiality agreement, held on the consultant’s machine only and deleted by a date you agree.
You receive
- Each of the thirteen elements marked: found (with your document and page), not found, or needs a person to judge
- The gaps ordered by how often cleared summaries in your code state each element
- Each gap phrased as a question to answer before filing
Format: PDF and Word, every statement footnoted. Typical turnaround: within a week of receiving the reports.
What it is not
- A finding that the evidence is insufficient — a gap is a question
- A statement about the FDA's decision
The FDA decides. Every deliverable says so on its cover.
What usually comes next
S4, to assemble the submission.
Talk through S3 for your device
The first S1 brief for your device is free. A twenty-minute call is enough to start: what the device does, where you are, and the date you are working to.