Precedium

Terms · September 2026

The terms on which Precedium is offered

These terms apply to the workspace at app.deviceevidence.com, offered by Device Evidence. By signing in with a Consultant Licence key you accept them. They are written to be read; where a clause is also enforced by the software, it says so.

  1. 1. What Precedium is, and is not. Precedium is a drafting workspace. It produces content organised to the section structure of a 510(k) submission and the FDA’s eSTAR template, exported as DOCX and PDF. It is not the eSTAR and does not fill or validate it. It is not regulatory advice. It makes no prediction of, and no statement about, the FDA’s decision on any submission, and nothing in the product, its exports or its correspondence should be read as one.
  2. 2. You are the author of record. Every export is your document. You review, edit and approve its contents before you use them, and you are responsible for what you submit. The workspace records your decisions with a time; it does not make them. Where a sentence has no source, the workspace prints it as not stated and lists it in the not-exported appendix rather than inventing one.
  3. 3. Your documents stay with you. No document you add is transmitted to us or stored by us. Documents are parsed, indexed and stored in your browser, and leave it only as an archive you export, encrypted under a passphrase we never see. The site’s security policy names the only addresses page script may contact, and a build check fails if the code ever gains a route that accepts a document. When drafting with a language model is offered, only the passages selected for one section are sent, only when you draft that section, and they are not retained by us; you may use your own key at a model provider you choose from the workspace’s list so that they do not pass through us at all. Each listed provider’s data terms are shown beside it, with the date we read them, and are listed on the privacy page; those terms, not ours, govern what that provider does with what you send it.
  4. 4. What a project fee buys. One project: the workspace for one submission, its stated token allowance for drafting, exports without limit, and the project’s versions. It does not buy our review of your draft, which is a separate purchase, and it does not buy any outcome. A purchase is recorded against the licence that claims it and may be attached to one project at a time.
  5. 5. Refunds. A project that is not usable for its stated purpose within seven days of purchase is refunded in full. Write to the contact address below with the time of purchase.
  6. 6. The corpus and the licence. The record the workspace draws on is Device Evidence’s, read under your Consultant Licence, whose own terms apply: the licence is personal to one named person; quotation with attribution is permitted; redistribution of the corpus is not. The corpus is an analysis of what public clearance summaries disclose. It is not an assessment of any device’s safety or performance, and the absence of a reported figure in a summary does not mean a device was not tested.
  7. 7. Not the FDA. Device Evidence and Precedium are not affiliated with, or endorsed by, the U.S. Food and Drug Administration. FDA documents are quoted with their dates; the FDA’s own pages are the authority on its procedures.
  8. 8. Corrections. A finding in Device Evidence’s record that is corrected is corrected in the workspace at its next fetch. If you relied on a corrected finding in an export, and we can identify that from a purchase, we tell you, as Device Evidence’s own corrections policy promises. Corrections and right of reply: deviceevidence.com/corrections.
  9. 9. Liability. Precedium is provided as a tool for your own work. To the extent the law allows, our liability for any claim arising from its use is limited to the fee you paid for the project concerned. We are not liable for the outcome of any submission, which depends on your work and the FDA’s review.
  10. 10. Changes. These terms carry their date at the top. A change is published here with a new date, and a purchase is governed by the terms in force when it was made.

Contact: hello@precedium.com. Read with how it works, which describes what the software does with your documents in more detail.