FDA approved vs. FDA cleared: Why you need to know the difference
The Food and Drug Administration is responsible for telling us which foods, medicines and medical devices are safe for us. Most of us assume that everything that has been approved or approved by the FDA has been rigorously tested, but that’s not always true.
There is a big difference between a drug or a medical device FDA approved and those who are FDA approved. Given the fact that more and more technical products are being checked by the FDA, it is important to understand the difference.
I have to give my hat to John Oliver of Last Week Tonight to get inspiration for this guide. In his episode of June 2, 2019, he discussed the dangers of using older medical devices to obtain FDA approval, which I will explain below.
What does the FDA regulate?
For the most part, the Food and Drug Administration assesses the safety and effectiveness of:
- Prescription drugs for humans and animals
- Over-the-counter medication
- Biologicals (e.g. vaccines, blood products, biotechnology products and gene therapy)
- Dietary supplements (not all are subject to the FDA regulation)
- Medical devices (everything from tongue depressors to pacemakers)
- Surgical implants
- Food additives
- Products that emit radiation (e.g. X-rays, microwave ovens)
- Tobacco products
- Baby food
What does “FDA Approved” mean?
“FDA Approved” means that the agency has determined that the “benefits of the product outweigh the known risks for its intended use.” Manufacturers must submit a PMA (Premarket Approval) application and the results of clinical tests to obtain approval.
When deciding to approve a product or drug, the FDA must decide whether the benefits outweigh the risks. The FDA is usually inclined to approve a higher risk product when the potential benefit is significant – like an artificial heart valve that can save someone’s life.
Which products must be approved by the FDA?
FDA approval is usually mandatory to market or sell products in the United States that are at significant risk of injury or illness, but may also benefit your health – such as prescription drugs, over-the-counter medicines, vaccines, and Class III medical devices.
The FDA categorizes Class III, Class II, and Class I medical devices. Complex medical devices that are implanted in your body, are life-sustaining, or may cause significant injury or illness to your body are Class III. This includes implanted pacemakers, replacement heart valves and even breast implants.
Lower risk devices and products that are used outside the body, such as condoms, motorized wheelchairs and bandages, fall into Classes II and I. As a reference, Apple’s ECG app for Class II belongs to the Apple Watch.
What does “FDA approval” mean?
Class II and I medical devices are usually “approved” by the FDA, which means that the manufacturer can demonstrate that their product “essentially corresponds to another (similar) legally marketed device” that already has an FDA approval or – Approval. These already released products are called predicate.
For example, suppose Apple wanted to hypothetically create a pacemaker that uses the same design and features as an existing one. The company could get FDA approval if it can compare its product with another that is already on the market and can show that it is just as safe, effective and works the same way.
Companies must provide the FDA with a “Premarket Notification Submission” or 510 (k) to review and delete the product. As soon as the FDA declares that a new medical device is essentially a predicate, it is “released” and can be marketed and sold in the United States.
The system is not perfect
The problem with the FDA approval system, as John Oliver emphasized, is that companies often release their product using older predicates that were later recalled for security reasons.
Just because a device has been approved or approved by the FDA does not always mean that it is safe. For this reason, you’ll see class action lawsuits asking if you or a loved one has used an FDA-approved product and has sustained physical injury or has died as a result. These defective products caused significant health problems despite being approved or released.
It is important to understand that the FDA does not develop any of the products that it evaluates for approval. It also does not run its own tests. Instead, it reviews the results of independent laboratory and clinical tests to determine whether the product, drug, or food additive is safe and as effective as it is supposed to be.
Which consumer tech products are approved by the FDA?
This is by no means a complete list of medical device and products recently approved by the FDA. Some of the things we’ve covered at CNET are:
Why is that important?
More and more technology companies are developing products that measure vital functions and can pay attention to patterns in your heart rhythm that in the past could only be done by professional health devices. We will only see more consumer health technology devices in the coming years, and many will be approved by the FDA.
Despite the ongoing problems with releasing products based on older, unsafe predicates, do not let this label turn you off. Most of these consumer devices are non-invasive or likely to cause significant physical injury. But when the day comes when Apple develops a Class III device, you are at least well informed to understand the implications.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a doctor or other qualified healthcare provider if you have any questions about an illness or health goals.