FDA Approved vs. Cleared: What’s the Difference?

By Karyn Repinski • Medically reviewed on October 12, 2020, by Dr. Emil Tanghetti, a board-certified dermatologist in Sacramento, California

The U.S. Food and Drug Administration (FDA) oversees the safety and efficacy of a broad range of products, including medical devices and drugs. The difference between FDA approval and clearance can be confusing. Here’s what you need to know to make safer decisions about aesthetic procedures.


What falls under FDA regulation?

In the realm of medical aesthetics, the FDA regulates these types of devices:

  • Lasers and pulsed-light

  • Ultrasound

  • Radiofrequency 

  • Electromagnetic 

  • Thermal and freezing 

  • Breast implants

  • Tissue scaffolding materials

  • Sutures, including those used in thread lifts

  • Injectable implants

“Injectable implants” is the FDA’s term for dermal fillers, like Juvéderm and Restylane. The agency considers fillers to be “prescription devices” (because the filler remains in the body until it breaks down), saying that they “should only be injected and sold by or on the prescription of a licensed healthcare provider.

The FDA also regulates topical treatments like Retin-A and injections like Botox and Kybella as drugs. 

In the eyes of the FDA, drugs include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body.” Almost any ingestible, topical, or injectable product that claims to be beneficial in these ways is regulated as a drug—except those that are considered to be an “injectable implant” device, like a filler. 

New drugs require FDA approval before they can be legally sold in the U.S. via prescription. The new drug application (NDA) process is long and expensive, but prescription drug approval means that the drug is safe and effective “when used as directed,” with health benefits that outweigh known risks. 

Devices, on the other hand, must be either FDA-cleared or approved to be legally sold in the U.S. 

The FDA has international counterparts with their own regulatory approval systems. Even if a drug or device is approved in another country, it must be FDA-cleared or approved to be legally sold in the U.S.


Why are some devices FDA-approved, while others are FDA-cleared?

The FDA uses a risk-based approach to regulating medical devices, categorizing them into one of three classes—Class I, II, or III—based on their potential risks and similarity to devices that are already on the market (aka “predicate” devices). FDA-registered devices are awaiting classification by the agency, based on their intended use and known risks. 

Class I and II devices (90% of all medical devices) are usually FDA-cleared, which means that: 

  1. The manufacturer has shown that their device is substantially equivalent (very similar) to another device that already has FDA approval or clearance, or 

  2. The FDA doesn’t think it poses a significant health risk.

When manufacturers apply for clearance, they outline their device’s similarities to a previously approved or cleared one, in a process called a Premarket Notification 510k. If the FDA agrees that it’s similar enough to be safe and effective for similar uses, they clear it for sale and marketing.

The bottom line: When the FDA approves or clears a class I or II device, it's saying that it believes the device is safe.

Class III devices (10% of medical devices) are considered higher risk, so their approval process is more involved.

The FDA defines Class III devices as those that:

  • Sustain or support life

  • Are implanted (like breast implants)

  • Present a potentially unreasonable risk of illness or injury

Before they can be legally sold and marketed, they must undergo the FDA’s Premarket Approval (PMA) process, which includes a rigorous review of the manufacturer’s results from laboratory tests, animal testing, and human clinical trials. As with drugs, FDA approval of medical devices means that the benefits outweigh the known health risks. 

The FDA always specifies the uses for which a drug or device was evaluated and approved—it doesn’t issue blanket approval for any use. For instance, in July 2020, the FDA approved Juvéderm Voluma XC for the augmentation of the chin region in adults over the age of 21, after previously approving it for “deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.”   


What does “off-label” use mean?

Providers commonly use drugs and devices for uses beyond their FDA-approval or clearance, using their own clinical judgment to determine safe and effective use. In fact, “off-label” treatment often lays the clinical groundwork for more approved uses in the future.

“Some of the most common cosmetic interventions in the U.S. are off-label uses of drugs and devices,” says Dr. Lara Devgan, a plastic surgeon practicing in New York City. “A few examples include toxins to slim masseter muscles, fillers in the undereye or tear-trough area, nonsurgical rhinoplasty, Sculptra for butt augmentation, and Kybella for dissolving bra-roll fat. These procedures have been performed thousands or even hundreds of thousands of times by medical professionals.”

Dr. Emil Tanghetti, a dermatologist practicing in Sacramento, California, agrees. “The use of drugs off-label is very common and includes their use in conditions we treat in dermatology everyday,” he explains. “For example, in treating acne, the use of many antibiotics is common, without these agents being FDA-approved to treat the condition. In the treatment of psoriasis on the face and in sensitive areas, we commonly use pimecrolimus cream. This drug is approved for atopic dermatitis, but those in the field know that it's very helpful for our psoriatic population.”

It’s smart to be aware of whether a treatment you’re considering is an FDA-approved or off-label use, and whether it carries risks you want to avoid. However, the most important factor is the experience level of your doctor, and whether they have the skill and clinical expertise to safely treat you.