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‘FDA Cleared’ vs. ‘FDA Approved’: What’s the Difference?

Ellen Gutoskey
A literal stamp of approval.
A literal stamp of approval. / Bet_Noire/iStock via Getty Images
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Since misinformation and disinformation are so easily spread online these days, people are relying more than ever on messages from trusted institutions like the U.S. Food and Drug Administration (FDA). But fully understanding those messages can sometimes necessitate a bit of research. Case in point: the difference between "FDA Approved" and "FDA Cleared."

For starters, the FDA doesn’t “approve” companies that manufacture or distribute medical products. It does typically require those companies to register and renew that registration on a yearly basis, but that doesn’t mean the FDA has approved their products. Furthermore, the FDA doesn’t issue registration certificates to those manufacturers—so if a business touts some sort of FDA certificate alongside its products, it’s a red flag. And if you see phrases like “FDA Registered” or “FDA Certified,” there may be some shady marketing going on. (Mammography facilities are one big exception to this rule: The FDA does have to certify them, and they have to visibly display their certificates.)

What the FDA does approve is specific products: food additives, drugs, certain medical devices, etc. "FDA Approved" means that the FDA, in its own words, “has determined that the benefits of the product outweigh the known risks for the intended use.” It makes that determination after reviewing all the clinical testing done by the manufacturer. As CNET explains, FDA approval is generally needed for things that could pose serious health risks, such as medications and vaccines. Also in that category are medical devices in Class III—the highest-risk category. According to the FDA, these items “usually sustain or support life,” like pacemakers.

For many moderate-risk items in Class II, from catheters to powered wheelchairs, there’s FDA clearance. This designation essentially means that the manufacturer has shown their product to be similar enough to another product on the market—called a “predicate”—that the FDA decides it’s safe to OK. Many products in Class I are considered so low-risk (think bandages and exam gloves) that the FDA exempts them from even needing clearance.

In short, "FDA Approved" and "FDA Cleared" are both valid labels to see on medical supplies; while "FDA Registered" and "FDA Certified" are not. And if you want to make sure a certain item actually has the approval or clearance its packaging claims, you can search for it in the FDA database.

[h/t CNET]

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