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Explainer · 2024

FDA cleared vs approved: what it means for devices

This publication shares ownership with PeptaraLabs, Lab Ranked Agency, and Dental Link.

The editorial panel, The BioHacking Awards
Posted on June 17, 2024 · Published on June 17, 2024

FDA cleared vs approved is a question that comes up every time a new wearable or health gadget says it has "FDA status." The two words are not the same. They describe different levels of review, and the label on the box rarely tells you which one applies.

Here is the short answer. "Cleared" usually means a device passed a comparison review, called a 510(k). "Approved" is reserved for the strictest review, called premarket approval, or PMA. Many consumer gadgets have neither, and that can be perfectly legal.

Why the FDA sorts devices by risk

The FDA puts medical devices into three classes. Class I is lowest risk. Class II is moderate risk. Class III is the highest risk. The FDA says Class III devices are those that support or sustain human life, matter a great deal in preventing harm to health, or carry a potential, unreasonable risk of illness or injury.

The class decides the review path. The FDA also says the right submission type is usually set by a device's classification, which anyone can look up in its public product classification database. A pulse oximeter for a hospital and a novelty step counter do not face the same bar, and that is on purpose.

Sources: FDA, How to Study and Market Your Device (fda.gov, Device Advice, as archived June 2024); FDA, Premarket Approval (PMA) (fda.gov, as archived June 2024).

What "cleared" means: the 510(k) path

A 510(k) is a premarket notification. The maker shows that the new device is substantially equivalent to a device already legally on the market. That older device is called the predicate.

The FDA says a device can be substantially equivalent if it has the same intended use and the same technology as the predicate. It can also qualify with different technology, if that difference does not raise new questions of safety and effectiveness. The maker must also show the device is as safe and effective as the predicate. The new device does not have to be identical.

The FDA says this decision is usually made within 90 days. Once it is granted, the maker may sell the device. That is why people say a device is "cleared." The FDA looked at the comparison and agreed the device could go on sale. It did not run a fresh, full test of safety from scratch.

Sources: FDA, Premarket Notification 510(k) (fda.gov, as archived June 2024).

What "approved" means: the PMA path

PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III devices. The FDA says general and special controls alone are not enough for these devices. So the maker must apply for approval under section 515 of the Federal Food, Drug, and Cosmetic Act.

The FDA also notes that it charges a fee for reviewing a PMA. A Class III device that does not meet PMA requirements is considered adulterated and may not be marketed. This is the high bar, and it is the only route the FDA describes as leading to marketing "approval."

In plain terms, "approved" is the stronger word. If a company says its product is "FDA approved," ask whether it went through a PMA. For most consumer wearables, the honest answer is no.

Sources: FDA, Premarket Approval (PMA) (fda.gov, as archived June 2024).

De Novo: the path for new kinds of devices

Some devices are new, and no predicate exists. The FDA created the De Novo route for novel devices where general controls, or general and special controls, are enough to give reasonable assurance of safety and effectiveness. A maker can come to this path after a 510(k) comes back "not substantially equivalent," or can request it directly.

If the FDA grants a De Novo request, the device is authorized for sale. A new classification is set up for that type of device. The device can then serve as a predicate for later 510(k) filings from other makers. The FDA also posts the granting order and a public decision summary. The word used is "granted," not "approved" and not quite "cleared." Many people still shorten it to "cleared."

Sources: FDA, De Novo Classification Request (fda.gov, as archived June 2024).

The fourth category: general wellness products

Many wearables sit outside all three paths. In its General Wellness guidance, issued on September 27, 2019, the FDA said it does not intend to examine low risk general wellness products to see whether they are devices, or whether they meet premarket review rules.

The guidance describes a general wellness product as one meant only for general wellness use that also presents a low risk to users. Its examples of general claims include weight management, physical fitness, relaxation or stress management, mental acuity, and sleep management. Tracking sleep trends is one of the examples it gives.

The guidance draws a line at disease claims. Claims that a product will treat or diagnose a condition fall outside it. The FDA's examples include a claim that a product will treat obesity or help treat an anxiety disorder. A device that makes claims like those may be regulated as a device and need a review path.

The guidance is described as nonbinding, so it states the FDA's current thinking rather than a new law.

Sources: FDA, General Wellness: Policy for Low Risk Devices, guidance for industry and FDA staff (issued September 27, 2019).

How to read a product claim

The FDA keeps public databases of 510(k) and PMA decisions. Searching a product code there takes a few minutes and is the best way to check a claim yourself.

One limit is worth stating. A clearance covers a stated use, not every feature in an app. A watch may have one cleared feature and several general wellness ones, and the label should say which is which.

Sources: FDA, How to Study and Market Your Device (fda.gov, as archived June 2024); FDA, Premarket Notification 510(k) (fda.gov, as archived June 2024).

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