FDA Registered, Cleared, Approved: What’s the Difference?

If a company wants to sell a medical device, it needs to let the FDA know about the device. How much and what type of information must be shared with the FDA, however, depends on the potential risks to users (and/or patients).

The FDA puts medical devices into three different buckets, creatively listed as Class I (low risk — think bedpans), Class II (higher risk — think exercise equipment and pregnancy test kits), and Class III (highest risk — think pacemakers). What classification bucket the medical device falls into will determine the applicable FDA “label” for the product — from FDA registered or listed, to FDA cleared and FDA approved. Which is to say, it is primarily a measure of risk that decides how a device ends up marketed as FDA listed or FDA approved or somewhere in-between.

Here’s a breakdown of the different classes:

• Class I products: Forty-seven percent of medical devices fall into this category. Class I devices are generally not subject to any premarket review by the FDA but still must register with the FDA. These products are sometimes marketed as “FDA registered” or “FDA listed,” but that’s like saying you’re on a guest list for entry into a nightclub that pretty much everyone gets into.
• Class II products: A slightly smaller percentage of medical devices, 43 percent, fall into this category. Before a Class II product can be sold it must show the FDA that it is “substantially equivalent” to another product that the FDA has already given clearance, which is known as a predicate device. The reasoning goes that if it’s pretty similar to another “cleared” product then it’s as safe and effective as the other device. Imagine the review process for Class II devices as a giant game of dominoes where every new product needs to match up to one that is already on the table. It’s not that hard to do, though that did not stop one marketer from citing FDA clearance in support of claims that its Class II laser therapy caps have no side effects and are clinically proven to regrow hair (claims that the marketer would be forced to discontinue). Because it’s not that rigorous a review standard, when you see something marketed as “FDA cleared,” it’s sort of like someone saying, “I’m good at dominoes” — it’s just not that impressive.
• Class III products: Class III devices, on the other hand, must be impressive in order to be sold to consumers. Class III products (about 10 percent of all medical devices) are subject to a rigorous review process by the FDA, and are eventually known as “FDA approved” devices. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.

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