The Food and Drug Administration is responsible for telling us which foods, drugs and medical devices are safe for us to use. And while we assume that anything that’s been cleared or approved by the FDA has been rigorously tested, that’s not always true.
There’s a big distinction between a drug or medical device that’s been FDA approved and those that are FDA cleared. Given that more and more tech products are being vetted by FDA, it’s important to understand the difference.
I have to tip my hat to John Oliver from Last Week Tonight for the inspiration for this guide. In his June 2 episode, he covered the dangers of using older medical devices to get FDA clearance, which I’ll explain below.
What does the FDA regulate?
For the most part, the Food and Drug Administration evaluates the safety and efficacy of:
- Prescription drugs for humans and animals
- Over-the-counter drugs
- Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)
- Dietary supplements (not all are subject to FDA regulation)
- Medical devices (everything from tongue depressors to pacemakers)
- Surgical implants
- Food additives
- Products that give off radiation (e.g. X-rays, microwave ovens)
- Tobacco products
- Infant formula
What does ‘FDA approved’ mean?
“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.
What products need to be FDA approved?
FDA approval is usually mandatory to market or sell products in the US that might have a significant risk of injury or illness, but can also benefit your health — such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.
The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, are 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 condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple’s ECG app for the Apple Watch is in Class II.
What does ‘FDA cleared’ mean?
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 Samsung wanted to create an app that can record a singlechannel electrocardiogram (ECG, aka EKG), which is what Apple’s ECG app does. It could get FDA clearance if it can compare its product to Apple’s and demonstrate that it is safe, effective and equivalent in how it works.
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.
The system isn’t perfect
The problem with the FDA’s approval system, as John Oliver pointed out, is that often companies get their product cleared by using older predicates that were recalled for safety reasons.
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.
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.
Which consumer tech products are FDA cleared?
This is by no means an exhaustive list of medical tech devices and products that have been recently cleared by the FDA, but a few we’ve covered at Techhnews include:
Why does this matter?
Apple’s latest foray into health tech — first making it possible to conduct an EKG on the Apple watch, and the soon-to-be-available, which can protect you against hearing loss — is proof that hospital-grade healthcare is making its way into the mainstream. We are only going to see more consumer health tech devices in the coming years, and many will be FDA cleared.
Despite the ongoing problems of products getting cleared based on older, unsafe predicates, don’t be turned off by that label. Most of these consumer devices won’t be invasive or likely to cause significant bodily harm. But if the day ever comes when Apple creates a Class III device, at least you’ll be informed enough to understand the implications.