In June 2026, an AI tool called UpDoc announced it was "FDA cleared." [6] News coverage described it as an artificial intelligence that could act as a "concierge doctor." [7] The clearance was real. What it covered was actually narrower than the phrase suggests. [9]
First, and worth noting, FDA cleared is still very impressive but its also important to realize what each statement means.
"FDA cleared," "FDA approved," and "FDA registered" sound similar, and marketers use them as if they mean the same thing. They do not.
Each one tells you something specific about how much the Food and Drug Administration (FDA) actually reviewed a product before it reached you, and the differences are large.
Here is a plain-language guide to the labels you will see on health apps, wearables, and at-home tests, and what each one does and does not promise.
The short answer
"FDA approved" is the strictest label. It means the FDA reviewed evidence and decided a product's benefits outweigh its risks before it could be sold. [1] Prescription drugs and the highest-risk devices clear this bar. [1]
"FDA cleared" is a lower bar. It means the maker showed the FDA that the product is "substantially equivalent" to a product already on the market, and the FDA agreed it could be sold. [2] Most medical software and many devices reach the market this way.
"FDA registered" or "FDA listed" is not a review at all. It means a company told the FDA its facility or product exists. [1] The FDA states plainly that registration "does not denote approval" of the product. [1]
The rest of this guide explains the labels in order, from the strictest to the loosest.
The five labels you will see
1. FDA approved
This is the strictest label in the list. For new prescription drugs and biological products, a company must show the FDA that the product is safe and effective for its intended use before selling it. [1] For the highest-risk devices, called Class III (for example, a mechanical heart valve or an implanted pump), the maker must submit a premarket approval (PMA) application with valid scientific evidence of safety and effectiveness. [1] When you see "FDA approved" used correctly, a review of the evidence happened first.
2. FDA cleared
Most moderate-risk devices, called Class II, reach the market through a process called 510(k) clearance. [1] Here the company does not have to prove the product is the best, or even run a new study. It has to show the FDA that the product is "substantially equivalent" to a device already legally on the market, called a predicate. [2] The FDA's review confirms the new product has the same intended use and does not raise new safety questions. [2] That review can include clinical data, or it can rely on lab and software testing alone. [2]
Software as a medical device (SaMD), the category most health apps fall into, usually arrives this way. Clearance means the FDA agreed the product is similar enough to something already sold. It does not, on its own, tell you a clinical trial was run.
3. FDA authorized (the De Novo path)
When a product is genuinely new and has no predicate to compare against, but is low to moderate risk, the FDA can grant it through a process called De Novo classification. [3] This creates a new category and sets the controls future similar products must meet. You will sometimes see this described as "FDA authorized." It is a real review, and it is the path for first-of-a-kind tools that do not fit the 510(k) mold.
4. Breakthrough Device Designation
This one is easy to misread, so read it carefully. The FDA's Breakthrough Devices Program gives certain products faster, closer attention while they are still being developed. [4] In June 2026, the radiology AI company Aidoc received a Breakthrough Device Designation for one of its tools. [8] A designation is a status during development. It is not a clearance and it is not an approval, and the product cannot be marketed for that use on the strength of the designation alone. [4] If an ad leads with "FDA Breakthrough," check whether the product was actually cleared or approved afterward.
5. General wellness, or not reviewed at all
Many of the health products people use every day are not reviewed by the FDA before sale. Fitness wearables and general wellness apps usually fall under the FDA's "general wellness" policy, which covers low-risk products that promote a healthy lifestyle rather than diagnose or treat disease. In June 2026, the FDA closed a warning letter to WHOOP after the company's revised Blood Pressure Insights feature was treated as general wellness rather than a regulated device. [5] Dietary supplements sit here too. The FDA does not approve them for safety and effectiveness, and the agency notes that many supplements can be sold "without even notifying the FDA." [1] Cosmetics are the same. [1]
A side-by-side comparison
Label | What it means | Evidence the FDA saw first | Example |
|---|---|---|---|
FDA approved | Reviewed and judged safe and effective before sale | Clinical trials for drugs; valid scientific evidence for Class III devices | Prescription drugs; implanted devices |
FDA cleared (510(k)) | Shown "substantially equivalent" to a product already sold | Moderate: may or may not include a new clinical trial | Many software tools and diagnostics, including UpDoc's insulin tool |
FDA authorized (De Novo) | New, low-to-moderate-risk product with no predicate | Moderate: device-specific controls | Some first-of-a-kind software |
Breakthrough Device Designation | A priority-attention status during development | None yet: it is not a clearance or approval | Aidoc's radiology AI |
General wellness / not reviewed | Not reviewed before sale | None | Most fitness wearables and apps; supplements |
What "cleared" does and does not tell you: the UpDoc example
UpDoc is a useful case because the clearance is recent and the record is public. The company sells health systems an AI tool that helps a patient with type 2 diabetes follow an insulin plan a doctor already set. [6] On June 25, 2026, it announced 510(k) clearance, number K253281. [6][9]
Read the FDA's own clearance document and three facts stand out. [9] First, the cleared product was found substantially equivalent to a device called d-Nav, which has been on the market since 2018. The underlying job, an insulin-dose calculator that follows a doctor's protocol, is not new. Second, the FDA record states that "no clinical testing was performed" for this clearance. It was cleared on equivalence to the older device, not on a fresh trial. Third, the cleared use is specific: medication management for adults with type 2 diabetes, under a clinician's plan. It is not cleared to diagnose, and it is not cleared to manage other conditions. [9]
None of this makes UpDoc a bad product. The point is narrower. "FDA cleared" told you the FDA agreed it resembled an approved approach closely enough to be sold. It did not tell you the product was tested in a new trial, and it did not cover everything the marketing implied.
How to check a claim yourself
You do not have to take a company's word for it. Three quick checks:
Ask cleared, approved, or neither. If a product says "cleared," it went through 510(k) and was compared to something already sold. If it says "registered" or "listed," the FDA did not review the product itself. [1]
Look up the clearance. The FDA keeps a public database of 510(k) clearances, and approved devices and drugs are listed too. [2] Search the product or company name and read the clearance letter. It names the indication, which is the exact use that was cleared.
Read the indication, not the ad. The cleared or approved use is often narrower than the headline. UpDoc's clearance covers insulin dosing for type 2 diabetes, not "AI primary care." [9]
For a related habit worth keeping, the same skepticism applies to credentials. Our guide on whether your concierge doctor is actually a physician walks through verifying the human on the other side of your care.
What this means for your health decisions
A label is a starting point, not a verdict. "FDA cleared" is meaningful, and it is also a low-to-moderate bar that frequently involves no new clinical trial. "General wellness" means no review happened before sale. Neither label tells you whether a tool is right for your specific situation, because the FDA reviews products, not people.
That judgment is what a doctor provides. An app can flag a glucose trend or a high resting heart rate. A physician decides what it means for you, given your history and your other conditions. If you are managing something real, like the diabetes, hypertension, or heart disease in our guide on concierge care for chronic conditions, the cleared tool is one input and the doctor is the decision-maker. If you want help finding that doctor, our guide on how to choose a concierge or direct primary care physician is a good next step.
Find a doctor, not just a label
An FDA label tells you how much the agency reviewed a product. It cannot tell you what is right for your body. That is a conversation with a physician who has time to know your history. NextMD lists concierge and direct primary care practices across the country. You can search by city, compare pricing, and view doctor credentials at nextmd.ai/search. Practices like Coastal Concierge Physicians in San Diego and memberships across California offer that kind of access.
Sources
U.S. Food and Drug Administration. (2026). Is It Really 'FDA Approved'? FDA Consumer Updates. Read the FDA consumer guide
U.S. Food and Drug Administration. (2024). Premarket Notification 510(k). FDA Center for Devices and Radiological Health. Read the FDA 510(k) page
U.S. Food and Drug Administration. De Novo Classification Request. FDA Center for Devices and Radiological Health. Read the FDA De Novo page
U.S. Food and Drug Administration. Breakthrough Devices Program. FDA Center for Devices and Radiological Health. Read the FDA Breakthrough Devices page
MobiHealthNews. (2026, June 26). FDA closes warning letter to WHOOP over Blood Pressure Insights feature. Read on MobiHealthNews
UpDoc. (2026, June 25). UpDoc Debuts First FDA-Cleared Clinical AI Platform Built for Real-Time Patient Care Delivery and Intelligent Care Coordination. PR Newswire. Read the announcement
Wall Street Journal. (2026, June 24). UpDoc's AI Gets FDA Nod to Act as 'Concierge Doctor' Between Visits. WSJ Pro Venture Capital. Read on WSJ
Modern Healthcare. (2026). AI Tracker: FDA grants Aidoc breakthrough designation. Read on Modern Healthcare
U.S. Food and Drug Administration. (2025, December 23). 510(k) Premarket Notification K253281 (UpDoc). FDA Center for Devices and Radiological Health. Read the FDA 510(k) summary