Most people are familiar with the U.S. Food and Drug Administration, also known as the FDA. But did you know the FDA has a role in evaluating the safety and efficacy of products used in cosmetic procedures?
When researching different cosmetic procedures, patients are often confused by the terms FDA approval vs. FDA clearance. Are they essentially the same thing?
It turns out they’re not.
The Distinction Between FDA Approval vs. FDA Clearance
There’s actually a significant difference between FDA approval and FDA clearance. The two terms refer to different levels of regulatory scrutiny for certain cosmetic surgery devices and products.
Products and devices are sorted by Class I, II, and III. Class I requires the least amount of regulation, while Class III products must adhere to the most stringent regulations. In a nutshell, FDA-approved products are subject to more rigorous testing than FDA-cleared devices.
FDA Approval
FDA approval is assigned only to Class III medical devices and prescription drugs. These are products that have the potential to pose more risks. Therefore, they require extensive testing to prove their safety and efficacy. Breast implants and BOTOX® injectables fall into this category.
Products that are FDA-approved are extensively researched. There’s a five-step process to gain approval that starts preclinical research which is followed by human clinical trials. In addition, manufacturers have to provide comprehensive data that demonstrates the product performs as intended and the benefits outweigh any potential risks. The process is lengthy and typically takes anywhere from eight to twelve years. This ensures that FDA approval is granted to only the most rigorously tested products.
FDA Clearance
By contrast, FDA clearance is reserved for Class I and II devices. These are considered to carry a low to moderate risk. Some of the non-invasive treatment tools used in cosmetic surgery fall into these categories. These can include microneedling devices as well as a handful of laser treatments.
While FDA-cleared items gain faster entry into the market than those that are FDA-approved, they still have to adhere to safety standards. The process is not as stringent though because in this case, a manufacturer has to prove that their new device is substantially equivalent to one that’s already been legally marketed. As such, proving that a device is at least as safe and effective as its predecessor takes considerably less time – typically a few months to a few years.
How Can You Know?
Not every procedure involves the use of a device that requires FDA approval or clearance. If you’re curious about yours, it’s important you verify that anything being used has the proper regulatory status.
Unfortunately, less reputable practices or medical spas have a history of counterfeit devices that can cause a range of problems and health issues. So your first line of defense is to insist on having your procedure performed at only highly respected practices.
A reputable provider will be transparent about the regulatory status of anything they will use for your procedure. Then you can use the FDA’s database to confirm that information.
Choose Only Experienced and Board-Certified Plastic Surgeons
Now that you’re clear on the FDA approval vs. FDA clearance distinction, you can move toward your chosen procedure with a more peaceful mind.
So if you’re looking for a board-certified plastic surgeon who will focus on the highest standards of care, contact us today to schedule a consultation.
We’ll discuss the safest and most effective path for your chosen procedure that will deliver beautiful results while prioritizing your well-being.