S2 · Planning validation
Evidence plan
Your study plan set against what cleared devices in your code actually reported — element by element, with the pages.
- 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
Development: you are planning the validation study or a Pre-Submission.
The question this week
“What will our validation have to show, and what should we ask the FDA before we run it?”
Who it is for
- Regulatory and clinical leads planning a validation study
- Teams preparing a Pre-Submission (Q-Sub) meeting
- Statisticians who want the precedent before they size the study
The problem
- Studies are designed without seeing what peers in the same code reported, so elements the FDA usually sees are missed.
- Pre-Submission questions come out vague, and the one meeting is spent on things the record already answers.
- Reading the precedent by hand takes weeks of someone senior's time.
You send
- Your intended use
- Your draft validation plan or protocol outline
- The product code, if known (S1 settles it if not)
Under a signed confidentiality agreement, held on the consultant’s machine only and deleted by a date you agree.
You receive
- Thirteen evidence elements — sample size, cohort demographics, design, sensitivity, specificity, AUC, reference standard, comparator, sites, prospective collection, outcomes
- For each: how often cleared summaries in your code state it, and up to three passages where they did, with the K-number and page
- Your plan beside the precedent, in your words
- Candidate Pre-Submission questions drawn from where your plan and the precedent diverge
Format: PDF and Word, every statement footnoted. Typical turnaround: one to two weeks from receiving the plan.
What it is not
- A protocol — your clinical and statistical leads own the study design
- A judgment that any evidence is sufficient
The FDA decides. Every deliverable says so on its cover.
What usually comes next
S3, once the study reports exist.
Talk through S2 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.