The launch catalog: what makes the cut

The hardest part of building a document library is not writing documents. It is saying no to most of them. A shelf that ships everything becomes a landfill with a search box; the value is the curation, and curation means criteria you can state out loud.

Every resource in the launch catalog had to pass four tests. They're worth publishing, partly so contributors know the bar, and partly so you can hold us to it.

The four criteria

Rebuilt often. The document has to be one teams actually recreate — the 510(k) checklist, the CAPA log, the document-control SOP. If most companies only ever need one, a template mostly transfers formatting, not craft, and it doesn't make the shelf.

Expensive when wrong. Priority goes to documents where a structural gap has a blast radius: a submission that bounces at intake, an audit finding, a lost review cycle. A meeting-minutes template is rebuilt constantly and costs nothing when mediocre — so it loses to the Q-Sub request template, which is rebuilt rarely but steers what FDA will actually answer.

Mapped to a primary source. If we can't anchor the document's structure to something authoritative — a regulation, a named guidance, a standard's clause — we can't maintain it honestly, and neither can you. This rules out "best practice" documents that are really just one firm's habits.

Maintainable. Sources move, so every resource needs an owner watching its source. A small catalog where every item states the revision it was built against beats a big one quietly going stale. This is the criterion that keeps the launch count at twenty-four rather than two hundred.

What we won't template

Some documents fail a fifth, unwritten test: they pretend judgment is fill-in-the-blank. A regulatory strategy memo, a substantial-equivalence argument, a clinical evaluation's benefit-risk rationale — the value of these documents is the reasoning, and a template that scaffolds the headings while faking the thinking is worse than a blank page, because it looks finished. Where judgment is the product, the Toolkit will ship the checklist that interrogates your reasoning, not the document that impersonates it.

Why the tools run in the browser

The catalog's interactive pieces — the classification decider, the timeline estimator, the RTA readiness scorer now in build — follow one rule: nothing about your submission leaves your machine. These tools work from your answers to structured questions, entirely client-side. Regulatory teams shouldn't have to send device details to a stranger's server to find out whether their file is ready, and with these tools the question never comes up.

Free at launch, and the ask

Everything on the launch shelf ships free. The honest reason: a commons has to demonstrate value before it has any standing to charge for anything, and the estate this site belongs to is built on that sequence — publish first. What we ask instead: when a template saves you the afternoon, send back the improvement. The shelf gets better the way any commons does — use, criticism, and returned repairs. And if you want to know the moment it opens: one email.