FDA regulates AI-enabled medical devices through the same pathways as other devices: 510(k) clearance, De Novo classification and premarket approval. Marketing follows the same logic. A cleared AI tool may promote the uses FDA cleared and should say cleared, never approved, while a tool without clearance should avoid claims about diagnosing or treating disease. FDA lists over 1,600 authorized AI-enabled devices as of September 2026.
By the Everything-PR Editorial Team
Published October 22, 2026. Updated October 22, 2026. Sourced from FDA pages, the Code of Federal Regulations and peer-reviewed research.
The good news for health tech brands is that the rules are stable and learnable. This guide explains what FDA's words mean, how to match a claim to a clearance, and where AI software falls outside device regulation. It closes with a claims table that communications teams can use in review meetings.
Key points for communications teams:
- FDA regulates devices, not AI as such, so the claim must match the authorized device and its indications for use
- Cleared devices should be described as cleared. FDA approval language is for premarket approval only
- Marketing and clearance records do not always match, so "uses AI" needs a record to back it
- Some clinical software and general wellness tools sit outside device regulation if they stay inside defined limits
Table of contents
- How does FDA regulate AI-enabled medical devices?
- What can a company say after FDA clearance?
- What can cleared and uncleared AI tools claim?
- Do AI marketing claims match the clearance?
- When is AI software not a medical device?
- How should teams review claims before launch?
- Frequently asked questions
How does FDA regulate AI-enabled medical devices?
FDA states on its AI-enabled medical devices page that it does not regulate AI as such, and that it regulates medical devices, including those that use AI. Devices reach the market through a premarket pathway such as 510(k) clearance, De Novo classification or premarket approval.
FDA also reviews changes to a device after authorization. Modifications that could significantly affect safety or effectiveness need FDA review, and FDA has issued guidance on predetermined change control plans for AI-enabled device software functions. Those plans let a manufacturer describe planned updates in advance.
FDA keeps a public list of authorized AI-enabled devices and reports that it has authorized over 1,600 as of September 2026. FDA notes that the list is not a comprehensive resource of every AI-enabled device. For communications teams, the list is a useful first check: a product that is absent may simply be missing from the list, but a product that claims authorization should have a record behind it. Everything-PR covers the wider rulebook for the sector in its health tech PR guide.
What can a company say after FDA clearance?
A company with a 510(k) clearance can say its device is FDA cleared, and should avoid the word approved. The federal regulation on misbranding by reference to premarket notification, 21 CFR 807.97, says a substantial equivalence determination does not denote official approval, and that any representation creating an impression of official approval is misleading.
In practice, that gives marketing teams three simple habits. They can say cleared and name the cleared use. They can say registered only as a factual statement, because registration with FDA is not approval. And they can reserve approved for products that completed premarket approval.
The clearance also belongs to a specific device and a specific use. A claim about a new feature, a new patient group or a new condition needs its own check against the cleared indications for use.
What can cleared and uncleared AI tools claim?
Cleared AI tools can claim what the clearance supports, and uncleared tools can claim wellness and information functions, not diagnosis or treatment. The table below summarizes common claims. It is a communications checklist built from the FDA sources linked in this article, not legal advice.
| Claim type | Cleared or authorized AI tool | Uncleared AI tool |
|---|
| "FDA cleared" | Allowed when the exact device has a 510(k) clearance and the wording names the cleared use | Not allowed |
| "FDA approved" | Reserved for devices approved through premarket approval. Cleared devices should say cleared | Not allowed |
| "FDA registered" | Factual only. Must not imply approval or endorsement | Factual only. Must not imply approval or endorsement |
| Detects, diagnoses or triages a condition | Allowed within the cleared indications for use | Avoid. Such a claim can make the product an unauthorized device |
| "Uses AI" or "AI-powered" | Allowed when the authorized device includes that AI function | Allowed when accurate and not tied to a medical claim |
| Supports clinician decisions | Allowed within the cleared use | Allowed for qualifying clinical decision support that lets clinicians review the basis for its output |
| Sleep, fitness or stress insights | Allowed | Allowed for general wellness claims that avoid disease references, under FDA's General Wellness policy |
| New model version or updated accuracy | Check the clearance and any change control plan first | Substantiate every performance number |
Do AI marketing claims match the clearance?
Most do, but not all. A peer-reviewed systematic review indexed in PubMed Central compared 119 public 510(k) summaries with the marketing materials for the same devices and found that 80.6% were consistent, 6.7% were contentious and 12.6% were discrepant.
The authors noted that some devices were marketed as having AI or machine learning capabilities that the FDA clearance did not cover. For a brand, that finding is a reason to keep a short evidence file for every AI claim: the clearance number, the indications for use and the page of the 510(k) summary that describes the AI function.
That file also helps with journalists, health system buyers and AI search engines, which tend to quote pages that state a regulatory status plainly and link to the record behind it.
When is AI software not a medical device?
Some AI software falls outside the medical device definition, mainly clinical decision support meeting statutory criteria and general wellness products with low risk. FDA's Clinical Decision Support Software guidance, issued in January 2026 and re-issued on January 29, 2026, says not all clinical decision support software used in healthcare settings is a device.
The guidance explains how FDA reads the criteria in section 520(o)(1)(E) of the FD&C Act, including that the software supports a clinician rather than replacing clinical judgment. FDA also updated its General Wellness policy on January 6, 2026, according to law firm summaries of the update, and the revision addresses wearables that report physiologic measures.
Companies in these categories still need accurate claims. Staying outside device regulation depends on the intended use the marketing communicates, so a brand that adds a diagnostic promise to a wellness product can change its regulatory status through its own copy.
How should teams review claims before launch?
Teams should review AI health claims in a fixed order before any launch, so every sentence maps to a record. This sequence works for press releases, websites, sales decks and social posts.
- Identify the product's regulatory status: cleared, approved, authorized through De Novo, or not a device.
- Pull the clearance or authorization record and the indications for use.
- Match each claim to that record, including any AI or machine learning wording.
- Replace "approved" with "cleared" wherever the pathway was 510(k).
- Check for new features or populations that the record does not cover.
- Send the final copy through medical, regulatory and legal review, then archive the evidence file.
Brands that run this routine tend to move faster, because reviewers get a complete package and fewer rounds of edits.
Sources: FDA, Artificial Intelligence-Enabled Medical Devices, FDA, Clinical Decision Support Software guidance, 21 CFR 807.97, and a systematic review of AI device marketing and 510(k) clearance.
Related links: Health Tech PR: Strategy, Rules, and Agencies, GEO for healthcare, and 5W PR, creative and GEO agency.
