📡 ⛲️ 🔬 What is the difference between “approved by the FDA” and “approved by the FDA” 🧖🏽 🍊 🌀

FDA approval will receive more and more consumer electronic devices. And here is what you need to know about this.

The United States Food and Drug Administration (FDA) is tasked with telling Americans which foods, drugs, or medical devices are safe to eat. And although many believe that everything approved and approved by the FDA goes through rigorous testing, in reality this is not always the case.

There is a big difference between medicines or medical devices that have been approved by the FDA [cleared] and approved by the FDA [approved]. And considering that today more and more electronics go through the hands of the FDA, it’s important to understand this difference.

What regulates the FDA?

For the most part, the FDA assesses the safety and effectiveness of the following products:

Prescription drugs for humans and animals.
Over-the-counter medicines.
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Approved by the FDA [FDA approved] means that "the benefits of the product outweigh its known risks when used properly." To obtain this approval, manufacturers must apply for a PMA (pre-market authorization) form and attach the results of clinical testing.

When deciding whether to approve the use of a product or drug, the FDA must decide whether its benefits outweigh its risks. Typically, the FDA is inclined to approve the use of a high-risk product if there are significant benefits from its use - as, for example, in the case of an artificial heart valve that can save someone's life.

What products must be approved by the FDA?

In the United States, approval is usually given to products that are supposed to be advertised or sold there that present serious risks in terms of injuries or illnesses, but which also involve health benefits, such as prescription drugs, non-prescription drugs, vaccines, and class III medical devices.

The FDA divides medical devices into three categories - I, II and III class. Sophisticated medical devices implanted in the body, supporting life, or potentially causing injury or disease, belong to class III. This includes implantable pacemakers, heart valve replacement, and even breast implants.

Low-risk devices used outside the body - condoms, motorized wheelchairs, dressings - fall into Classes II and I. For example, the Apple Watch ECG removal app is in Class II.

What does “FDA Approved” mean?

Class I and II medical devices typically receive “FDA cleared” approval when a manufacturer can demonstrate that their product is “substantially equivalent to another similar and legally advertised” device that is already approved or approved by the FDA. Such already approved products are called predicates.

Suppose that, hypothetically, Samsung wants to create an application that records a single-channel ECG - which Apple already knows how to do. Then the company will be able to get approval from the FDA by comparing its product with the EPL product and showing that it is safe, effective and equivalent in principle.

Companies must submit a statement to the FDA in form 510 (k), a “pre-market notice statement,” so that it can examine the product and permit its use. Once the FDA announces that a new medical device is substantially equivalent to a predicate, it is considered “authorized” and can be advertised and sold in the United States.

The system is not perfect

The problem with this system, as noted earlier, is that often companies use older predicates to get permission from the FDA, which were subsequently withdrawn for security reasons.

Just because the FDA has approved or approved the device does not mean that it is safe. That is why you can see a class action advertisement looking for people or relatives of people seriously injured or even killed by using products approved by the FDA. Such defective products can ultimately significantly affect health, despite their permission or approval.

It is important to understand that the FDA does not develop products that evaluate and authorize. It does not conduct its own tests - it simply studies the results of tests conducted in independent laboratories and clinics to determine whether the device, medicine or dietary supplement is as safe and effective as the manufacturer claims.

What consumer products and electronic devices are approved by the FDA?

This, of course, is not a complete list of medical devices recently approved by the FDA - just a list of the ones we described recently:

Monarch trigeminal nerve stimulation system , which sends weak electromagnetic pulses to the nervous system to treat attention deficit hyperactivity disorder.
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KardiaMobile 6L AliveCor, .
Verily Study Watch Alphabet, .
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Apple’s latest breakthrough in the field of devices for maintaining health - first an ECG application, and in the near future - a Noise hearing protection program - proves that such devices are already entering the mass market. In the coming years, their number will grow, and many of them will be authorized by the FDA.

Despite the problem that many products are allowed to be used on the basis of equivalence with older and unsafe predicates, you should not turn your back on the “FDA approved” mark. Most of these devices will not be invasive and are unlikely to harm your body. But if Apple ever creates a class III device, you will at least know enough to understand the consequences of using it.

What is the difference between “approved by the FDA” and “approved by the FDA”