FDA Approved vs. Authorized vs. Cleared

Here is the short version, up front: approved, authorized, and cleared describe three different review paths, for different kinds of products, with different levels of evidence behind them. “Approved” is the strongest claim, and it applies mainly to new drugs and the highest-risk medical devices. “Cleared” usually means a moderate-risk device was shown to be substantially equivalent to a device already on the market. “Authorized” usually means the product was allowed onto the market under a special, often temporary, authority — most famously an Emergency Use Authorization, or EUA — on the basis of less evidence than a full approval would require.

If you read one thing in this article and nothing else, make it this: when you see an FDA word in a headline, stop and ask which product it refers to, and which of the three words was actually used. The answer tells you how much evidence the FDA has seen, how long the permission lasts, and what the agency has — and has not — decided about the product.

This is a reader’s guide, not medical advice. It explains how to read FDA announcements. It will not tell you whether any particular product is right for you. For that, talk to a doctor or pharmacist, not a headline.

The One Idea Behind All Three Words

The FDA regulates a huge range of products: human drugs and biological products, animal drugs, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. But Congress did not give the agency the same job for every product. For some products, the law requires the FDA to review safety and effectiveness before the product can be sold. For others, the agency’s main role begins after the product is already on shelves. That difference — decided by Congress, not by the FDA — is why the same agency uses three different words.

Think of it this way. The FDA does not stamp every product with one seal of quality. Instead, it runs different gates for different products, and each gate has its own name. The word in the announcement tells you which gate the product went through.

That is also why “FDA approved” can be a misleading phrase when it is used loosely. Many products the FDA regulates never go through an approval process at all. If a company says its shampoo or its vitamin supplement is “FDA approved,” the claim is wrong on its face, because the FDA does not approve cosmetics or dietary supplements. We will come back to that in the section on what the FDA does not approve.

Approved: The Full Review

“Approved” is the word the FDA uses when it has completed its fullest review of a product and decided the evidence supports marketing it for a specific use.

New drugs and biological products

With rare exceptions, a new drug or biological product for people must be FDA approved before it can be marketed, offered for sale, or shipped across state lines. To win approval, the company must show that the drug is safe and effective for its intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the drug outweigh the risks for that intended use — or, in the case of a biological product, that it is safe, pure, and potent.

Biological products that go through this route include therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products made from plasma. The FDA also approves generic drugs and biosimilar medicines — versions of existing drugs that increase competition and can lower prices.

Two things about drug approval are worth knowing, because headlines often get them wrong. First, the FDA does not develop the products it approves. The agency’s experts evaluate laboratory, animal, and human clinical testing done by the manufacturer. Approval is a judgment about the manufacturer’s evidence, not a prize for a product the agency invented. Second, approval is tied to a specific use. A drug approved to treat one condition is not automatically approved to treat another. When a company talks about a new use for an already approved drug, that new use needs its own evidence and, in most cases, its own FDA decision.

The highest-risk medical devices

Devices are handled differently from drugs, because a device can be anything from a tongue depressor to an implanted heart valve. The FDA sorts medical devices into classes by risk, and the class decides which gate the device goes through.

The highest-risk devices — Class III — generally require FDA approval of a premarket approval application, known as a PMA, before they can be marketed. Mechanical heart valves and implantable infusion pumps are the FDA’s own examples. To receive approval, the manufacturer must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance the device is safe and effective for its intended use. That is a demanding standard, and it is the device world’s closest equivalent to a drug approval.

So when you see “FDA approved” attached to a medical device, it usually means one of two things: the device is a high-risk, Class III device that went through the PMA process, or someone is using the word loosely and you should check. Most devices you will read about are not in this category.

What approval does not mean

Approval is a serious decision, but it is not a guarantee. It does not mean a drug works for everyone, or that it has no side effects, or that it is the best treatment available. It means that, on the evidence the FDA reviewed, the benefits outweighed the risks for the intended use, in the population studied. The agency continues to monitor approved products after they reach the market, and it can require new warnings, restrict a product’s use, or pull it from the market if new safety information emerges.

Approval also does not mean the FDA checked every claim a company makes in its advertising. Companies are responsible for marketing their products truthfully, and the FDA polices misleading promotion — but a glossy ad that says “FDA approved” is not itself an FDA statement. The approval is the agency’s decision, recorded in its own documents. Everything else is the company’s telling of it.

Cleared: Substantially Equivalent to Something Already on the Market

“Cleared” is the word for the most common device pathway, and it is the one most often confused with approval.

Most moderate-risk medical devices — Class II devices, such as dialysis equipment and many types of catheters — may be marketed once they have received what is called 510(k) clearance. The name comes from section 510(k) of the Food, Drug, and Cosmetic Act. To get clearance, the manufacturer must demonstrate that the new device is “substantially equivalent” to a legally marketed device that does not require premarket approval. That earlier device is called the predicate device.

Read that carefully, because the logic matters. A 510(k) clearance does not necessarily mean the FDA reviewed fresh clinical trials proving the new device is safe and effective on its own. It means the FDA agreed the new device is close enough to a device already on the market — in intended use, technology, and performance — that it can be marketed on the strength of that comparison. The predicate device itself may have been cleared the same way, years earlier. Clearance is a chain, not a fresh verdict on every link.

That is not a criticism of the pathway. For moderate-risk devices, comparing a new version to a known device is often a sensible way to regulate: a slightly improved catheter does not need the same evidence as a brand-new implantable heart valve. But it does mean “cleared” and “approved” describe different amounts of evidence. A cleared device has been found substantially equivalent to a predicate. An approved device has been found, on its own evidence, to offer a reasonable assurance of safety and effectiveness.

Low-risk devices — Class I, such as non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves — are subject to general controls only, and most are exempt from premarket notification altogether. You will rarely see an FDA word attached to them, and if you do, be skeptical: there is usually no FDA decision to describe.

How to hear “cleared” in a headline

When a company announces that its device is “FDA cleared,” the useful questions are: cleared for what use, exactly, and what is the predicate device? The clearance covers a specific intended use. A device cleared to monitor one thing has not been cleared to diagnose something else, even if the company’s press release implies a broader victory. And because clearance rests on equivalence, the more a new device differs from its predicate — new technology, new patient population, new claims — the more you should want to see the FDA’s own clearance letter, not just the company’s summary of it.

Authorized: The Special-Circumstances Word

“Authorized” is the word the FDA uses when a product is allowed onto the market under a special authority that is narrower, more conditional, or more temporary than approval or clearance. There are three situations where you are most likely to meet it.

Emergency Use Authorization (EUA)

The best-known kind of authorization is the Emergency Use Authorization. During certain types of public health emergencies, when the Secretary of Health and Human Services declares that circumstances exist justifying emergency use, the FDA may issue an EUA to authorize an unapproved medical product — or an unapproved use of an approved product — to diagnose, treat, or prevent a serious or life-threatening disease or condition.

The legal bar for an EUA is deliberately different from the bar for approval. Before issuing one, the FDA must be satisfied that the agent involved can cause a serious or life-threatening disease or condition; that, based on the totality of the available scientific evidence, it is reasonable to believe the product may be effective; that the known and potential benefits outweigh the known and potential risks; and that there is no adequate, approved, and available alternative for the job. Note the language: “may be effective,” not “has been proven effective.” An EUA is a judgment made under emergency conditions, on the evidence available at the time, that a product is worth using while more evidence is still being gathered.

An EUA is also temporary by design. It lasts only for the duration of the emergency declaration, unless the declaration is terminated or the authorization is revoked sooner. The FDA can revoke an EUA as more evidence comes in. And an EUA for one use does not turn into an approval for that use: a product authorized for emergency use still needs to go through the full approval process if the company wants to market it permanently for that use.

This is the point that caused the most confusion in recent years. A product described as “authorized” during an emergency was sometimes reported as if it had been “approved,” and the two words were used as if they meant the same thing. They do not. An authorized product has met an emergency standard. An approved product has met the full standard. When the emergency ends, the authorization ends with it, unless the product has since been approved through the ordinary route.

De Novo authorization for new types of devices

There is a second, quieter kind of authorization. Some low- to moderate-risk devices are of a new type — there is no predicate device to compare them with, so the 510(k) route does not fit, but they are not high-risk enough to need a full PMA approval. For these, the FDA has a pathway called De Novo review. A device that goes through De Novo review may be authorized for marketing in the United States. You will see this word used for novel devices that are the first of their kind: not approved, not cleared, but authorized through De Novo. It is a real FDA decision, and it means the agency reviewed the device and allowed it onto the market — but it is worth knowing which pathway was used, because the evidence behind a De Novo authorization is different from the evidence behind a PMA approval.

Tobacco: authorized is not approved

A third use of the word shows up with tobacco products, and the FDA is unusually blunt about it. There is no such thing as a safe tobacco product, and the FDA does not approve tobacco products at all. To legally sell a new tobacco product in the United States, a company must receive authorization from the FDA — through a premarket tobacco product application, a substantial equivalence application, or an exemption from substantial equivalence. But a marketing authorization, the FDA says, does not indicate that the tobacco product is safe or “FDA approved.” It means the applicant has met the legal requirements to bring the product to market. If you ever see a tobacco product advertised as “FDA approved,” that is wrong, and the FDA’s own guidance says so.

The Comparison Table

Here is the whole picture in one place. Keep it next to you the next time a headline uses one of these words.

One more row belongs in the table, for the words that mean nothing at all: “FDA registered” and “FDA certified” are not FDA decisions about a product. We turn to those next.

The Words That Mean Nothing: Registered and Certified

If “approved,” “authorized,” and “cleared” are three different gates, “FDA registered” and “FDA certified” are not gates at all — and the FDA has a whole page explaining why.

Owners and operators of facilities that produce and distribute medical devices intended for use in the United States are generally required to register with the FDA each year, and to list the devices they handle. But when a facility registers and lists its devices, the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its devices. Registration is an administrative requirement. It is roughly the equivalent of a business filing its address with the authorities. It says the FDA knows the facility exists. It says nothing about whether the products are safe or effective.

The same is true of drug and device listings. Unless an exemption applies, drug, foreign food, and most device facilities must register before exporting products to the United States. Mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or any other product from that establishment, and it does not mean the product may be legally marketed.

As for certificates: the FDA does not issue any type of device registration certificate to medical device facilities. If a company shows you an “FDA certificate” for its facility, it did not come from the FDA. There is one narrow exception in the other direction — mammography facilities must be certified by the FDA, or by a state the FDA has approved as a certifier, and must display their certificates where patients can see them. That is a certification of a facility’s ability to provide quality mammography, not a product approval.

So when an advertisement says “FDA registered” or “FDA certified,” treat it as a warning sign, not a reassurance. The FDA’s own words are blunt: such words may be used to mislead you. The question is never “is the company registered?” The question is “was this product approved, cleared, or authorized — and for what use?”

What the FDA Does Not Approve at All

Part of reading FDA announcements is knowing which products never go through an approval process, so that an “FDA approved” claim about them can be dismissed on the spot.

Food. The FDA does not approve food products. It does approve certain ingredients before they are used in food — food additives and color additives, unless an exception applies — and companies must show those additives are safe for their intended use. But the food itself, the bag of chips or the loaf of bread, is not “FDA approved.”

Cosmetics. Cosmetic products and their ingredients and labeling do not require FDA approval. Perfumes, makeup, moisturizers, shampoos, hair dyes, cleansers, shaving preparations — none of them are FDA approved. The one exception is color additives (other than coal-tar hair dyes), which must be approved before use. A cosmetic advertised as “FDA approved” is misusing the term.

Dietary supplements. By statute, the FDA does not approve dietary supplements for safety and effectiveness. Many supplements can be marketed without even notifying the FDA. Companies must ensure their products are safe and comply with labeling and quality requirements, and they must submit a premarket safety notification at least 75 days before marketing supplements containing certain new dietary ingredients — those not marketed in the United States before October 15, 1994. But that notification is not an approval.

Compounded drugs. Compounding is when a licensed pharmacist or physician combines or alters ingredients to create a medication for an individual patient. Compounded drugs are not FDA approved. By statute, compounders do not need to prove to the FDA that their products meet the same standards drug manufacturers must meet, which means the FDA does not conduct premarket review of compounded drugs for safety, effectiveness, or quality.

Infant formula. The FDA does not approve infant formulas before they can be marketed, although new formulas are subject to premarket review and the agency can object to a product or ingredient. Manufacturers must register their facilities and submit new formula information at least 90 days before marketing, and the FDA inspects formula facilities at least once a year. Heavily regulated, yes. Approved, no.

Health care providers and manufacturing facilities. The FDA does not approve health care providers, including physician offices or laboratories, although it can inspect facilities to check compliance with legal requirements. Nor does the agency approve manufacturing facilities independently, even though facilities are often inspected as part of a product application and are frequently required to register.

Medical foods. Medical foods — formulated to be consumed under a physician’s supervision for the dietary management of a specific disease — do not undergo premarket approval by the FDA, although their makers must follow manufacturing and registration requirements.

If you remember only one sentence from this section, make it this one: the absence of an approval does not mean a product is unregulated, and the presence of regulation does not mean a product is approved. The FDA’s job varies by product, and the word in the announcement is the clue to which job it was doing.

How to Check a Claim on the FDA’s Own Website

Headlines compress. Press releases spin. The FDA’s own records do not. Here is how to verify a claim in a few minutes, using the agency’s own tools.

Start with the announcement, not the headline. Search the FDA’s press announcements for the product name. The announcement itself will use one of the three words — approved, cleared, or authorized — and will usually name the pathway: a new drug application, a premarket approval, a 510(k), a De Novo request, or an Emergency Use Authorization. If the announcement says “authorized” and the headline says “approved,” trust the announcement.

For drugs, check Drugs@FDA. The FDA keeps a directory of approved and unapproved finished drugs on the market, and a complete list of licensed biological products. Drugs@FDA is the public database where you can look up whether a specific drug is approved, and for which uses. If a drug is not there, or is listed for a different use than the one in the news, you have your answer.

For devices, check Devices@FDA. Devices@FDA is the FDA’s catalog of approved and cleared medical device information. You can search it by device name or company name. For devices that went through the De Novo pathway, there is a separate De Novo database. For products authorized under an EUA, there is a separate list of Emergency Use Authorizations for medical devices. The FDA’s own guidance points readers to exactly these databases — which is itself a useful habit: when the agency tells you where to check, go there.

Check the EUA list, and check the date. Because an EUA is tied to an emergency declaration, it can end. A product that was authorized in 2021 may no longer be authorized, or may have been authorized for one use and later approved for another. The EUA list shows the current status. A headline from two years ago does not.

Read the letter, not the summary. For the products that matter to you, the FDA publishes the actual decision documents — approval letters, clearance letters, and EUA letters of authorization. These are usually linked from the announcement or the database entry. The letter states the exact indication, the exact patient population, and any conditions the company must meet. A press release will tell you the good news. The letter will tell you the limits.

Watch for the recall connection. The FDA also publishes recall notices and enforcement reports, and the difference between those two documents is its own reading skill. Our companion piece explains how to compare an FDA recall notice with the agency’s enforcement report, and why the two documents can tell different stories about the same product: Compare an FDA Recall Notice With the Enforcement Report. A product that was approved or cleared can still be recalled, and a recall does not erase the original decision — it adds to the record.

This kind of checking is also the habit behind our other FDA explainers. When the agency publishes a research request or a new initiative, the announcement tells you what the agency is asking for or planning — not what it has proven. Our piece on the FDA’s ibogaine research request walks through that distinction in detail: FDA Ibogaine Research Request: What It Asked For, and What It Did Not Prove. And our look at the FDA’s neuroscience initiative applies the same question — what did the announcement actually say, and what evidence would it take to support the claims around it — to a different kind of announcement: FDA Neuroscience Initiative Announcement: What It Said, and What It Did Not Show.

The Mistakes Headlines Make Most Often

After reading enough FDA announcements, the same errors show up again and again. Here are the ones to watch for.

Calling a clearance an approval. This is the most common error, and the most consequential, because it upgrades the evidence in the reader’s mind. A device that was found substantially equivalent to a predicate is reported as “FDA approved,” and readers reasonably assume the agency reviewed full clinical trials. It may not have. If the announcement says “510(k)” or “cleared,” the headline should say cleared.

Calling an authorization an approval. Same error, higher stakes, because it usually happens during an emergency, when people are making health decisions quickly. An EUA is an emergency judgment on limited evidence. Reporting it as an approval removes exactly the information a reader needs most: that the evidence is incomplete, the permission is temporary, and the product may never be approved for that use.

Treating approval as a verdict on everything. A drug approved for one condition is sometimes reported as if it were approved for another condition the company is studying. Or a device cleared for one use is described as if it were cleared for a different, more exciting use. Approval and clearance are always tied to a specific intended use. The use is part of the decision.

Reporting “FDA registered” as if it meant something. As we have seen, registration is paperwork. A company that advertises registration as an endorsement is either confused or hoping you are.

Forgetting that decisions change. Approvals can be withdrawn. EUAs can be revoked. Clearances can be overtaken by new safety information. An announcement is a snapshot of a decision on a particular day. If the news you are reading is months or years old, check whether the decision still stands before you repeat it.

Confusing the agency with the company. “The FDA announced” and “the company announced” are different sentences. The FDA’s announcement is the agency’s own account of its decision. A company’s press release about an FDA decision is the company’s account of the agency’s decision. When the two differ — and they sometimes do, in wording that matters — the agency’s version controls.

Three Questions Before You Believe an FDA Headline

You do not need to memorize the Food, Drug, and Cosmetic Act. You need three questions, asked in order, every time you see an FDA word in the news.

1. Which word did the FDA itself use — approved, cleared, or authorized? Go to the FDA’s announcement, not the headline and not the company’s press release. The agency’s word tells you which review path the product went through, and how much evidence sits behind the decision.

2. Approved, cleared, or authorized for what, exactly? Find the specific use, the specific patient population, and the specific product. A drug approved for one condition is not approved for another. A device cleared for one purpose is not cleared for another. An authorization tied to an emergency ends when the emergency ends.

3. Can I find it in the FDA’s own database? Drugs@FDA for drugs, Devices@FDA for devices, the De Novo database for new-type devices, and the EUA lists for emergency authorizations. If the product is not in the database that matches the word being used, something is wrong with the claim — and it is worth finding out what before you pass it on.

Three words. Three gates. One habit: check the agency’s own record before you trust anyone else’s summary of it. The FDA’s language is precise for a reason. Once you know what each word means, headlines get much easier to read — and much harder to be misled by.

Sources

• U.S. Food and Drug Administration, “Is It Really ‘FDA Approved’?” — the FDA’s guide to what it approves and does not approve, including new drugs and biological products, Class III devices through premarket approval, Class II devices through 510(k) clearance, and the products it does not approve (food, cosmetics, dietary supplements, compounded drugs, infant formula, medical foods, tobacco, health care providers, manufacturing facilities). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
• U.S. Food and Drug Administration, “Are There ‘FDA Registered’ or ‘FDA Certified’ Medical Devices?” — registration and listing do not denote approval, clearance, or authorization; the FDA issues no device registration certificates; how to check approved and cleared products in Devices@FDA, De Novo devices, and medical device EUAs. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
• U.S. Food and Drug Administration, “Emergency Use Authorization of Medical Products and Related Authorities” (guidance for industry, January 2017) — EUA criteria and conditions, including the HHS Secretary’s declaration and the requirement that authorization lasts only for the duration of the declaration unless terminated or revoked sooner. https://www.fda.gov/media/97321/download
• U.S. Food and Drug Administration, Emergency Use Authorization fact sheets (2025–2026) — the EUA criteria as stated in current authorization documents: the agent can cause a serious or life-threatening disease or condition; based on the totality of available scientific evidence it is reasonable to believe the product may be effective; known and potential benefits outweigh known and potential risks; and there is no adequate, approved, and available alternative.
• Fact-check date: 2026-11-11. This article is a general explainer about how to read FDA announcements. It is not medical advice, and it does not assess any specific product. Product status should always be checked in the FDA’s own databases, because approvals, clearances, and authorizations can change.