Understand the differences between FDA Approved vs Cleared and Registered

Understand the differences between FDA registered, cleared, and approved and why these terms are critical to remaining safe and healthy.

FDA (Food and Drug Administration) is a familiar acronym for most of us, and we come across it in products or even at pharmacies and hospitals. You will see phrases like “FDA registered,” “FDA approved,” and “FDA cleared” on products you use daily, such as medicine and food. However, you probably don’t understand what all those phrases mean. You aren’t alone; many people have seen them but aren’t aware of what they mean.

Nonetheless, you’re in the right place. We’ll look at what each phrase means. There’s a significant difference between consumer health products such as smartwatches that are FDA approved, FDA registered and those that are FDA cleared. A lot of products that are coming up from technological innovations are regulated by the FDA. As long as health is concerned, It is essential to know how to differentiate everything.

What is the FDA?

Before understanding all the phrases, it’s essential to know what the FDA is and its role. The Food and Drug Administration is a government agency responsible for safeguarding the country’s public health. It’s in charge of monitoring whether consumer products are safe. Among the products that the FDA regulates include food, medical devices, tobacco, medicine, vaccines, products used in vet clinics, and radiation-emitting electronics.

It ensures products are effective, secure, and safe for public health. The agency’s responsibility is to protect consumers and ensure they access safe and more beneficial products. Manufacturers state a lot of benefits on their products; hence the FDA ensures everything works as stated. For example, medicine needs to be regulated to ensure it doesn’t cause harm when consumed. We have all heard of the Covid 19 vaccine saga and bumpy approval process.

What’s the meaning of “FDA approved?”

When a product is FDA-approved, it has been determined that it has more benefits than risks. Before the FDA approves products, a premarket approval (PMA) application, know as the premarket notification, and clinical testing results have to be presented by a manufacturer.

Drugs and any other products are approved after they’re analyzed to see the risks and benefits. If the risks outweigh whatever benefits products offer, then they won’t be approved.

However, if a product or medical device carries significant risk but at the same time the benefit is essential, then the FDA will approve it.

The FDA approval will be more or less stringent depending on the risk involved. Hence a pacemaker that will be surgically implanted in your body and regulate the heart rhythm will not fall into the same medical device class as plaster and bandage. The FDA categorizes different consumer health products into Class I, Class II, and Class III depending on the underlying risks.

Products that the FDA approves

Different products, including medical devices such as blood pressure monitors, must be approved and rigorously tested. If something is beneficial to your health or can cause injuries or fatality, the FDA must approve it.

Medical devices that need to be implanted in the body or offer life support fall under Class III; examples include breast implants or pacemakers, as we just saw. Other products used on the body externally, such as bandages or smartwatches, are under Class I and Class II depending on the level of risk they carry for the user.

In a nutshell, as long as a medical product deals with human health, it will need to be checked and approved by the FDA.

What’s the meaning of “FDA cleared?”

FDA cleared vs approved can be a confusing distinction. The FDA clears Class II and Class I medical devices. In simple terms, this means that a manufacturer can show that their product has the potential to perform and other similar devices in the market that have already been cleared and approved by the FDA. To be cleared, the manufacturer will not need to engage in huge and costly clinical studies. Instead, he will need to demonstrate that their product is as good as those already on the market.

So, for instance, if a company wants to manufacture a smartwatch with similar features to one already in the market, they have to prove that it can effectively perform the same way and is as safe as the competition.

Before reaching the shelves, manufacturers must ensure that they provide a 510(K), also known as a premarket notification, to the FDA. This will start the clearance process. Once the FDA determines the product is as good as a predicate, it is cleared and can be sold anywhere. A medical device that the FDA clears, such as a smartwatch to measure blood pressure or ECG, shows the product is reliable and has many benefits outweighing risks.

When it comes to products that the FDA clears, the list is endless. This is because so many products and medical devices are cleared daily. Examples of recent ones that have been cleared include the Apple ECG app. The app helps in monitoring electrical impulses from the heart through the Apple Watch Series 4. We recently selected the Apple Watch as one of the best ECG smartwatches.

Some companies will choose not to follow this regulatory path and indicate that their product is not a medical device and should not be used. This can be confusing as some cheap blood pressure monitors will not present themselves as medical devices and hence admits that the results they provide have little or no medical value at all. Therefore, always read the fine prints and check if the product you are about to purchase is compatible with medical use.

What’s the meaning of “FDA registered?”

Every medical device has to be “FDA registered” before it’s released into the United States market. In facilities where products are manufactured for consumers in the United States, the owners have to register with the FDA every year. The registration process, known as establishment registration, reviews owners’ information about their facilities and device listings.

A fee that Congress approved is also required every year from companies manufacturing for the establishment registration. The FDA is in charge of collecting the fees. When a facility registers with the FDA, they have to give details of manufactured devices and what they can do. It helps in dealing with emergencies that might occur due to the devices. In addition, it’s easy to locate the facility when the FDA has the registration and listing.

If a manufacturer changes anything on their devices, even packaging, they must ensure they are listed in the FDA’s Registration and Listing database. However, you should note that even if the FDA registers a device, this doesn’t mean that it’s useful in working as the manufacturer claims.

Registration doesn’t show the quality of products; it just shows the FDA knows they’re being manufactured. A manufacturer can’t claim the product is FDA cleared or approved. The reliability and performance of the product are only determined when it’s “FDA cleared.” You can report any problems you might experience from a device through Medwatch.

It’s risky purchasing and using products that aren’t “FDA registered” because they can be harmful. It can be dangerous and not perform as advertised. It can also cause you an injury that you didn’t expect. You’re also left exposed without protection if you’re a healthcare professional using products that aren’t listed. If you want to confirm whether different products are safe and effective, check the Registration and Listing database on the FDA website.

To wrap up

We hope that you understand a bit more about how the FDA preserves the health of the population. Then, depending on what you expect from a medical device, make sure that the necessary approval process has been diligently followed and that the product is safe to use.

An FDA clearance is already a good start for products aimed at the consumer market.

FDA approval and FDA registration are more complex and time-consuming to obtain. Yet, these stamps are somehow at the core of the healthcare system’s safety, and we should feel reassured when we see them.

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