Six situations, and where each one starts

A two-person team building an AI tool that flags suspected findings on chest CT.

The situation

They do not know their product code, and an investor has asked how the device reaches the market.

The work

The code finder proposes candidate codes from their indications sentence. The brief lists the most-cited predicates in the best fit, the code's recalls, and a reading of whether a De Novo request is worth considering.

What they had at the end

A sourced answer to the investor's question, and a predicate shortlist to read.

S1 · Regulatory pathway brief →

A twenty-person company with a triage device and a draft retrospective study.

The situation

Their statistician is sizing the study; their Pre-Submission meeting is in two months.

The work

The plan is set beside what cleared summaries in their code reported on each of thirteen elements. Where most peers state an element the plan does not cover, it becomes a Pre-Submission question.

What they had at the end

A study plan that covers what the precedent covers, and five specific questions for the FDA.

S2 · Evidence plan →

A regulatory lead with five finished test reports.

The situation

There is no second reader, and an additional-information request would cost the launch window.

The work

Each report is read against the thirteen elements. Ten are found with their pages; three are not, ordered by how usual they are in the code.

What they had at the end

Two gaps closed before filing, one documented as out of scope.

S3 · Validation gap review →

A company whose documents are ready and whose regulatory lead is stretched.

The situation

The equivalence table and evidence sections would take three weeks by hand.

The work

The predicate's column is quoted from its public summary with pages; sections are drafted from the company's own documents, every sentence cited and reviewed.

What they had at the end

Submission content in days, with a list of exactly what is still owed.

S4 · Submission drafting →

An independent regulatory consultant with three filings due in a month.

The situation

Each client needs a cross-read of the evidence before filing.

The work

S3 and S4 run as a subcontract under the consultant's agreement with the client; the consultant reviews and signs.

What they had at the end

The consultant keeps the client relationship and gets the week of assembly back.

S3 · Validation gap review →

A team whose device does something no cleared device does.

The situation

Every candidate predicate differs in intended use or output.

The work

The brief shows the closest devices and where they differ, and sets out what a De Novo request would rest on: the risks and the controls that would answer them.

What they had at the end

A reasoned case for discussing the De Novo route with the FDA early.

S1 · Regulatory pathway brief →