FDA Cleared vs FDA Approved

FDA Cleared vs FDA Approved. Let’s dive in!

There’s a big distinction between a drug or medical device that’s been FDA cleared and those that are FDA approved. Given that more and more medical device products are being vetted by the FDA, it’s important to understand the difference.

All manufacturers who seek to market medical devices in the United States must first pass a very thorough process with the FDA through one of two pathways—the section 510(k) process, where a device is “cleared” for distribution, or the Premarket Approval (PMA) process, where a device is “approved” by the FDA.

Today’s process stems from the Medical Device Amendments added to the Food, Drug and Cosmetic Act in 1976, establishing three regulatory classes for medical devices. Because there were devices already on the market prior to 1976, all devices were considered either pre-amendment medical devices, or new concept medical devices that had never been in commercial distribution (e.g., MRI, and lasers). The new devices had to undergo a PMA, a process that is significantly more expensive and difficult for the manufacturer, more like a new drug application ending in FDA “approval” due to the fact that there is no existing history of the medical device.

What does ‘FDA cleared’ mean?

FDA Cleared

FDA ‘cleared’ is for use in Trials.

Class II and Class I medical devices are usually “cleared” by the FDA, which means the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has FDA clearance or approval. Those already-cleared products are called a predicate.

For instance, let’s say hypothetically Apple wanted to create a blood pressure monitor, using the same design and features of one that already exists. The company could get FDA clearance if it can compare its product to another that’s already on the market and demonstrate that it is it just as safe and effective, and works in the same way.

Companies must submit a “premarket notification submission” or 510(k) to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is “cleared,” and can be marketed and sold in the US.

For submittal support – check here.

What does ‘FDA approved’ mean?

FDA Approved

FDA ‘approved’ is for distribution of products.

“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant — like an artificial heart valve that can save someone’s life.

For FDA approval, they categorize medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like motorized wheelchairs and catheters, fall into Class II and Class I.

Premarket Approval (PMA) for FDA Approval of New and Class III Devices

New medical devices, which are not similar in function, materials, design, or purpose to another device on the market, must submit a Premarket Approval (PMA) application to the FDA in order to be marketed and sold in the U.S. It is important to note that most medical devices DO NOT have to go through the Premarket Approval process.

Only new Class III medical devices need PMA approval. These are devices implanted into the body, life-sustaining devices (i.e. pacemakers), or otherwise pose a significant risk to the patient (i.e. PET scanning devices). Other FDA regulated products that need approval are products like prescription drugs, vaccines, and OTC medications. 

The PMA process requires the manufacturer of the device to provide valid evidence from human clinical trials that the device is safe to use and effective for the intended purpose.

IDE: Investigational Device Exemption

FDA Approved

To conduct human clinical trials, the manufacturer must obtain an Investigational Device Exemption (IDA). This allows the device to be distributed to the facilities listed in the exemption to conduct clinical trials and collect evidence needed for the PMA application.

FDA Approved means that, through this process, the device has shown that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers whose devices have FDA approval may market their devices as “FDA Approved.”

Is the system fool-proof?

It’s important to understand that the FDA does not develop any of the products it evaluates for approval. Nor does it conduct its own testing — instead, it reviews the results of independent lab and clinical testing to determine if the product, drug or food additive is safe and as effective as it claims to be.

Just because a device was FDA approved or cleared does not always mean it is safe. That’s why you see ads for class-action lawsuits asking if you or a loved one used a FDA-approved product, and suffered permanent bodily harm or died as a result. Those defective products ended up causing significant health problems, even though they were cleared or approved.

This is why medical device teams reach out for more data, because they want to avoid calamities and instead – keep patient safety first.

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