S4 · Ready to file
Submission drafting
The record half of a 510(k) or De Novo, assembled in days — every drafted sentence sourced and reviewed by a person.
- 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
Ready to file: the documents exist and the content needs assembling.
The question this week
“Can the submission content be assembled without losing three weeks to tables and checklists?”
Who it is for
- Companies preparing a 510(k) or De Novo with a small regulatory team
- Consultants who want the assembly done under their review
The problem
- The equivalence table, the evidence sections and the acceptance checklist take a senior person weeks.
- Every figure must trace to a page, and keeping that discipline by hand is slow.
- Drafting tools produce fluent text with no sources, which a reviewer cannot trust.
You send
- The full document set: test reports, device description, labeling, software documentation
- The predicate, if chosen
Under a signed confidentiality agreement, held on the consultant’s machine only and deleted by a date you agree.
You receive
- The substantial-equivalence table, the predicate's column quoted from its public summary with pages (or reference devices for a De Novo)
- Drafted sections in which every sentence cites your document or a predicate page, reviewed sentence by sentence
- The FDA's acceptance checklist, item by item, mapped to where each is met
- Change-control plan and human-factors sections from your answers
- A not-exported appendix listing every statement still owed — nothing unsourced is ever included
Format: PDF and Word, every statement footnoted. Typical turnaround: one to three weeks, depending on the document set.
What it is not
- A completed eSTAR — the content is organised to its sections and a person enters it
- A statement about the FDA's decision on the submission
The FDA decides. Every deliverable says so on its cover.
What usually comes next
Ongoing: a watch on your code, if you ask for one.
Talk through S4 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.