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.
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 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 has a significant risk but at the same time the benefit is essential, then the FDA will approve it.
Products that the FDA approves
Different products, including medical devices such as blood pressure monitors, have to be approved and rigorously tested. If something is beneficial to your health or can cause injuries or fatality, the FDA must approve it. Different consumer health products are categorized into Class I, Class II, and Class III by the FDA. Medical devices that need to be implanted in the body or offer life support fall under Class III; examples include breast implants. 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.
What’s the meaning of “FDA cleared?”
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 as well as other similar devices in the market that have already been cleared and approved by the FDA. The term predicate is used to refer to products that have been FDA cleared. For instance, if a company wants to manufacture a smartwatch with similar features to one that’s already in the market, they have to prove that it can effectively perform the same way and is as safe as the competition.
Manufacturers have to ensure that they deliver a 510(K), also known as a premarket notification, to the FDA. The agency then assesses the product and then clears it. Once the FDA determines the product is as good as a predicate, then it is cleared can be sold anywhere in the country. 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. 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.
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 the manufacturing of products meant for consumers in the United States occurs, the owners have to register with the FDA every year. The registration process, known as establishment registration, reviews information that owners present 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 devices being manufactured and what they can do. It helps in dealing with emergencies that might occur due to the devices. It’s easy to locate the facility when the FDA has the registration and listing.
If a manufacturer changes anything on their devices, even if it’s 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 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.