Intended use, claims and what they commit you to
“What am I allowed to say this does — and what happens to me if I say more?”
Intended use is the single most consequential sentence a founder writes. It determines which regulator, which pathway, which evidence and which postmarket obligations follow, and every one of those is downstream of a claim most teams draft in an afternoon.
WHAT THIS IS NOT
Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.
ARE YOU HERE?
- You are describing the product to investors, collaborators or a website, and the descriptions differ slightly between them
- Someone has asked what the product is "indicated for" and the honest answer is that you have not settled it
- A narrower claim would be easier to evidence and a broader one would be easier to sell
WHAT TO DECIDE NOW
- The intended use statement, written down, dated, and treated as a controlled document from the moment it exists
- Who the intended user is and in what setting — a claim for a trained specialist and the same claim for general practice are different products
- Which claims you are deliberately NOT making, recorded alongside the ones you are
START KEEPING THESE RECORDS NOW
- Every version of the intended use statement and what changed between them, because the evidence you gather is only valid for the claim it was gathered against
- Marketing and pitch material, which regulators read as evidence of intended use regardless of what the formal statement says
- The reasoning for excluding a population or setting, which is a defensible position only if it was a decision rather than an omission
THE PROBLEM THIS ANSWERS
The framework that governs a product cannot be settled from the technology, and the team has no written position on the three things that decide it — intended use, primary mode of action and jurisdiction.
What it costs: Every downstream decision is made against a moving target. Evidence is gathered for a claim that has not been fixed, so it may not be evidence for the claim eventually made.
NOT YET MEASURED — Sustained arrivals on /tools/regulatory-pathway-orientation, or the question appearing unprompted in office-hour sessions.
The claim, the risk analysis and the test plan are maintained by different people in different documents, so none of them constrains the others and no single artefact states what the product is for.
What it costs: A reviewer reads the promotional material as evidence of intended use and finds it disagrees with the evidence package. The mismatch is cheap to find and expensive to have.
NOT YET MEASURED — Founders arriving at the claims guide from promotional-claim wording searches rather than from classification searches.
WHERE THIS GOES WRONG
- Letting the website make a broader claim than the submission. Promotional material is evidence of intended use, and the mismatch is found easily.
- Writing the claim to match the data already collected, rather than collecting data against the claim you intend to make.
- Treating "research use only" as a durable position while selling to clinical users. What the product is used for outweighs what the label disclaims.
WHAT THIS DOES NOT ANSWER
- Whether the claim as drafted places the product in a particular class or pathway — this guide does not classify anything, and a classification opinion is worth getting properly rather than inferring here
- Whether a narrower first claim followed by expansion is the right commercial route, which is a business judgement with regulatory consequences rather than the reverse
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