To check an AI medical-device claim, identify the exact product and manufacturer, locate the relevant regulatory record and compare its authorised purpose with the claim being made. A badge is a signpost, not the evidence itself. An unsuccessful database search is also not proof that the supplier is acting unlawfully.
This is a verification workflow, not a legal opinion about a named product. The US and UK public sources were checked on 19 September 2026. Regulatory terminology and routes differ, so keep the jurisdiction attached to every conclusion.
Begin with the exact identity
Record the product name, manufacturer, version or configuration where relevant, and the specific function the supplier says is covered. Corporate names and product brands may differ. A company can sell several products under one website, and the regulatory record may concern only one of them.
Ask the supplier for the submission or authorisation identifier rather than searching a slogan. Preserve a dated copy of the claim being evaluated. If a brochure says "AI platform approved" but the cited record describes a narrowly defined imaging function, the discrepancy is the subject of the enquiry.
Do not resolve uncertainty by assuming either the best or worst interpretation. Request the scope. A supplier may have a legitimate explanation, such as a manufacturer name that differs from the trading brand or a version history that needs clarification.
Use the FDA list as an entry point, not an exhaustive register
The FDA's AI-enabled medical-device list, checked for this article, links to regulatory records and explicitly states that it is not comprehensive. Its identification process and publication timing mean that absence from the list does not establish absence of authorisation.
Follow the record link and inspect the available summary. Check the intended use, population, inputs, output and limitations. Note what the public document does not disclose. A summary is not necessarily the complete evidence submitted to the regulator.
The FDA also distinguishes routes and terminology. Its 510(k) guidance explains the substantial-equivalence pathway associated with clearance. Do not casually replace clearance, approval and other authorisation terminology with a single claim that every AI device has been "approved" in the same way.
Compare the claim and the record line by line
Use a small verification sheet:
| Item | Marketing statement | Regulatory record or supplier evidence |
|---|---|---|
| Product | Which named product is promoted? | Which product and manufacturer are listed? |
| Purpose | What does the supplier say it helps decide? | What is the documented intended purpose? |
| Users and setting | Who is expected to use it? | Which users and settings are covered? |
| Input and output | What data go in and what action is suggested? | What functionality is described? |
| Limits | What qualifications are visible? | What exclusions or conditions are stated? |
This is an original checking framework, not a substitute regulatory assessment. The useful result is a precise account of agreement, uncertainty or mismatch. Avoid a traffic-light score that compresses unresolved scope questions into a reassuring overall badge.
A fictional example of a scope mismatch
Suppose a fictional company markets software as supporting interpretation of a particular type of scan in a specified adult population. Its regulatory record covers that task. A sales presentation then suggests the same authorisation supports autonomous management recommendations across several specialties.
The appropriate response is not to declare the entire company unregulated. Ask which record supports the broader function, whether it is available or planned, and what human review is required. The original record may remain valid for its documented task while providing no answer to the broader claim.
The reverse mistake is also possible. A supplier may describe a function conservatively, while a buyer assumes that regulatory status means it can safely be deployed in a different setting. Scope checking is therefore a responsibility on both sides of the procurement conversation.
Keep UK terminology and evidence separate
For UK software questions, begin with the MHRA's medical-device software guidance and obtain the appropriate documentation for the product and market. Do not treat an FDA record as a complete answer to UK conformity, registration or deployment questions.
Likewise, distinguish a manufacturer or product registration from a regulator's endorsement of every output. A statement about one reference-tool component should not be reused as an educational outcome claim for a question bank. Regulatory status and teaching effectiveness require different evidence.
The practical question is not "Does this company have a badge somewhere?" It is "What supports use of this function, in this setting, for this purpose?" Record the answer in those terms so the conclusion remains useful when the product changes.
What to do when you cannot find the record
Check spelling, manufacturer identity, previous product names and the supplied identifier. Ask the supplier for the official source and an explanation of the claim. Keep a record of the search date and the databases consulted.
If the answer remains unclear, describe it accurately: the reviewed public material did not establish the claimed status for the specified function. That is narrower and more defensible than claiming the product has no authorisation. Escalate through the organisation's regulatory or clinical-safety expertise when the uncertainty affects a proposed deployment.
Do not turn an incomplete search into a public allegation. Equally, do not let a polished response replace documentary evidence. A supplier should be able to explain the relevant scope without requiring the buyer to infer it from unrelated marketing language.
Apply the same scrutiny to iatroX
This guide is published by iatroX and includes its own clinical reference and education platform in the scope discipline. Its standards page, checked on 19 September 2026, distinguishes different product functions. That public description should be read in context, not repurposed as a blanket clinical-validation claim.
For learners, inspect the actual learning experience. For organisational use involving clinical decisions, request function-specific documentation. Neither a large user count nor clinician-reviewed educational content substitutes for the regulatory record relevant to a particular medical-device claim.
Frequently asked questions
Does absence from the FDA AI list prove a product is unauthorised?
No. The FDA explicitly states that the list is not comprehensive, so check the underlying records and request the supplier's identifier.
Are FDA clearance and approval interchangeable terms?
No. Use the terminology associated with the actual regulatory route and record.
Does a regulatory badge prove that every AI answer is correct?
No. Read the documented purpose, conditions and limitations, and assess the evidence relevant to the intended deployment.
Discuss verification of clinical AI claims with iatroX Insights →