S1 · Idea / early design
Regulatory pathway brief
Which product code, which predicate, which pathway — read from every cleared device that came before yours.
- 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
Idea to early design: the device exists on paper or as a prototype.
The question this week
“Where does our device fit, and what has the FDA already cleared that looks like it?”
Who it is for
- Founders and CTOs of AI device start-ups without a regulatory lead
- Teams choosing between a 510(k) and a De Novo request
- Anyone preparing a fundraise who must explain the regulatory route
The problem
- You do not know which product code your device falls under, and the FDA databases do not answer the question directly.
- Choosing a predicate means reading dozens of clearance summaries; a poor choice is often found late.
- Nobody near you can say what cleared devices in your code had to show, or what was recalled.
You send
- A one-page description of the device
- Its intended use and indications, in a sentence or two
- Anything you already know about similar devices
Under a signed confidentiality agreement, held on the consultant’s machine only and deleted by a date you agree.
You receive
- The product codes considered, and why each was or was not chosen
- The predicate candidates in your code, ordered by how often later clearances cite them, with each one's lineage
- The code's record: how many devices cleared, what their summaries state, how long past reviews took, and recalls with their root causes
- A written reading of six pathway questions — predicate, technological differences, De Novo, Pre-Submission, change-control plan, and what to plan around
- Every statement footnoted to an FDA document page or to our reading of it
Format: PDF and Word, every statement footnoted. Typical turnaround: about a week from the call.
What it is not
- A determination of your device's classification — only the FDA makes one
- A statement about the FDA's decision on any submission
The FDA decides. Every deliverable says so on its cover.
What usually comes next
S2, when you plan the validation study.
Your first pathway brief is free
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.