How it works
Built from the record, assembled in your browser
Eleven steps from an idea to a document a person pastes into eSTAR. At most of them Precedium fills the page from the public record or from your own documents, and a person decides. Nothing is invented: every statement names where it came from, and a sentence with no source does not export.
Step by step: what you do, what Precedium does
| Step | What you do | What Precedium does |
|---|---|---|
| 1 Create the project from the record | Name it; pick the pathway and the mode (a submission, a feasibility profile, or diligence). | Finds the product code from your indications sentence: the codes whose cleared devices say what you say, each with its regulation name and the three closest statements, quoted. |
| 2 Device profile model, checked | Add the IFU, the software description and a test report. Accept, edit or reject each proposed field. | Reads the documents in your browser and proposes all fourteen fields, each resting on the passage it came from, with a flag on any figure the passage does not state. |
| 3 Predicate from the record | Choose one primary predicate and up to three reference devices. | Lists every cited device in the code with how often it is cited, what its summary reports, where its evidence sits, and how close its own indications statement is to yours - quoted, with the page. |
| 4 Base rates from the record | Read them. | Fetches what summaries in this code state: how many report each element, review times, recalls, change-control plans, with the capture date. |
| 5 Equivalence table record + you | Confirm the rows; quote the predicate where the corpus did not read that row; mark the rows that differ. | Fills the subject column from your profile, cited, and the predicate's column where the corpus read the summary, with the page. |
| 6 Evidence from the record | Confirm or refuse each proposed passage. | Runs the corpus's own reading rules over your documents and proposes the passage for each of thirteen elements, or says it found none. |
| 7 Draft model, checked | Accept, edit or reject every sentence. | Drafts each section from your profile, passages and predicate cells only; every sentence names its sources, every figure is checked against them, an unsourced sentence cannot export. |
| 8 Change control plan record + you | Answer eight questions. | Puts the code's precedent language beside each, and drafts the plan from your answers. |
| 9 Human factors record + you | Name the users, the environments and the tasks. | Maps each task to the guidance's considerations and flags the critical ones. |
| 10 Acceptance checklist record + you | Decide 38 items and say where each is met. | Proposes a state for every item the project can answer. |
| 11 Export from the record | Download; paste into the FDA's form. | Builds the DOCX and PDF with a footnote on every statement, a cover that says what was used, and an appendix of what was withheld. |
Where things live
What it reads
Device Evidence holds the FDA’s list of AI-enabled devices, every clearance document behind it, and a reading of each summary: thirteen elements of validation evidence, each with the sentence and page it was found on, the predicate each device declared, and the chain of predicates behind that. Precedium reads that corpus under your Consultant Licence. It copies none of it; every figure it shows carries its K-number and page.
What it does with your documents
You add your device description, test reports and protocols. They are parsed, split and indexed in your browser, and stored there, encrypted, in a project archive you can export and import. There is no upload route on this site: the security headers name the only addresses page script may contact, this site’s own and, if you choose to draft on your own key, the model providers on the workspace’s vetted list. Your IT can read that header. Only the passages selected for one section are sent, and you see them before they go.
What it produces
A chosen predicate with its lineage. A substantial-equivalence table with the predicate’s column pre-filled and referenced. An evidence checklist that reads your reports against what cleared devices in your product code reported, and says found, not found, or needs a person. The FDA’s current acceptance checklist mapped to your sections, for a person to tick. A DOCX and a PDF, organised to eSTAR’s section structure, with a sources appendix. A person pastes them into the FDA’s form.
What it never says
Whether the FDA will accept, clear or approve anything. Whether a submission is complete or compliant. Precedium prepares content; a qualified person reviews, edits and signs it. A sentence without a source does not export.