Terms of use

What this tool does, what it does not do, and who is responsible.

Draft — pending review by regulatory counsel. The product is not yet open to the public.

What this is

An analysis of a medical-device description against the FDA public record — classification, predicate, substantial-equivalence comparison, checklists, timelines — produced by rules and models, with the basis and the measured error rate shown beside every answer.

What this is not

• It is not regulatory, legal or medical advice, and no professional relationship is created by using it.
• It is not a submission, and it does not file anything with FDA.
• It is not a signature. A typed name here is a review record (21 CFR 820.180), not an electronic signature under 21 CFR Part 11.
• It does not replace a qualified person. Every value must be reviewed by one before it enters a filing — the product says so at the point of sign-off and will not pretend otherwise.

Reliance

Every answer carries the rate at which that kind of answer was wrong on past clearances (our error rates). Those rates are the limit of what you may rely on. Where the product sends a case to a person, or says a fact is not in the record, that statement is part of the answer.

Your document

1. OpenRouter receives the full text to pull out the structured fields — and, if the document is not in English, to translate it. Zero data retention is set on every request.
2. OpenAI receives the joined device fields, to find similar predicates. That route has no per-request retention setting, so it rests on the account terms.
3. This product keeps only the extracted fields on the audit record. This browser may hold an unfinished draft so a failed run is recoverable; a successful analysis deletes that draft and does not save the source document in the caseload. Predicate ranking runs on our own machine; the FDA, eCFR and Federal Register queries carry no text of yours.

We hold no data-processing agreement with either company on your behalf, and no retention commitment you could hold anyone to. This page describes what the software does, which is not a contract. For an unfiled 510(k), whose existence is confidential under 21 CFR 807.95, that is worth saying plainly.

What learns

A correction you make changes this dossier, is kept on its audit record, and — on this browser only — is offered back to you as a suggestion on your later dossiers, marked as yours and never applied on its own.

Nothing learned from one sponsor’s dossier is ever used in another’s: the existence of a submission is confidential (21 CFR 807.95), and so is everything in it.

Liability

To the extent the law allows, the product is provided as analysis of the public record, without warranty that any answer is correct for your device, and the provider is not liable for a filing, a decision, or a loss that relies on it without the review this page requires. Counsel’s final wording will replace this paragraph.