You have likely heard the terms FDA Cleared and FDA Approved, but did you know there’s a big difference between these two sound-alikes? And what does Emergency Use Authorization mean? The scope of The FDA is very broad, and to add to the confusion, FDA regulations can overlap with those of other government agencies.
What Does The FDA Regulate?
From The FDA‘s website, The FDA regulates:
- dietary supplements
- bottled water
- food additives
- infant formulas
- other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
- prescription drugs (both brand-name and generic)
- non-prescription (over-the-counter) drugs
- vaccines for humans
- blood and blood products
- cellular and gene therapy products
- tissue and tissue products
- simple items like tongue depressors and bedpans
- complex technologies such as heart pacemakers
- dental devices
- surgical implants and prosthetics
- microwave ovens
- x-ray equipment
- laser products
- ultrasonic therapy equipment
- mercury vapor lamps
- color additives found in makeup and other personal care products
- skin moisturizers and cleansers
- nail polish and perfume
- livestock feeds
- pet foods
- veterinary drugs and devices
- cigarette tobacco
- roll-your-own tobacco
- smokeless tobacco
How Does The FDA Regulate Plastic Surgery?
The three areas of Plastic Surgery which The FDA regulates are drugs, cosmetics and medical devices. Anything put into or used on the human body are within the FDA’s purview.
Most people are familiar with how this works for prescription medications. In order to sell a prescription drug, it must first be FDA Approved. Approval means the benefits of the product outweigh the known risks for the intended use. There are several phases to the approval process, but in the end medications must be safe and effective to gain approval. It is important to note that The FDA does not do any independent research, instead they review research and data provided by the manufacturer. They may also ask for additional data prior to approval, and follow-up data after approval.
The process works the same for implants such as Breast Implants, Cheek Implants, Chin Implants, nasal implants. I have participated in the follow-up research for all three US breast implant manufacturers, Allergan, Sientra and Mentor. These studies follow patients for decades, to demonstrate that breast implants continue to be safe and effective.
Fillers Are Implants Too
Another group of implants are dermal fillers. You may not think that Restylane and Juvederm and the myriad of other dermal fillers are implants, but that is how The FDA classifies them. These too have gone through safety trials and testing for efficacy and safety.
Drugs also require FDA approval. Both over-the-counter and prescription drugs have to be safe and effective before they can be marketed. For example, Botox is FDA approved for treating the frown lines. Specifically, to decrease the wrinkles that form between the eyebrows when we frown or concentrate. Once a drug is approved, it can be used in any manner a doctor dictates. Botox is used to treat wrinkles elsewhere on the face, even though these areas are not specifically FDA approved. This is called an “off label” use, Technically, the use of Botox for a patients younger than 18 and older than 65 is an “off-label” use too, because the research submitted to the FDA for approval only included patients 18 to 65 years old.
Lower risk products and devices used outside the body are usually FDA Cleared rather than FDA Approved. These items are less likely to cause injury, and as a result have a much lower standard to reach. Many FDA Cleared items do not have large clinical trials associated with them, and many are approved because they are “substantially equivalent to another (similar) legally marketed device.”
Lasers, even though they can cause severe injury, are not FDA Approved. That is to say, extensive safety and efficacy trials are not required. A laser that is FDA Cleared is felt to be safe because it is similar to another already cleared laser. The effectiveness of the laser may or may not have been tested. Even when tested, because lasers are not considered dangerous, the amount of “effectiveness” may also be very low. If a laser manufacturer is claiming FDA Approval, you should give them a very critical look. They are more likely FDA Cleared, but if they lack the understanding to know the difference, they may be misleading you in other areas also.
What’s the Difference Between FDA Approved and FDA Cleared?
FDA Approved is a higher standard, because the safety and effectiveness of the specific product has been tested. FDA Cleared is a lower standard, and in many cases the product is cleared because it is similar to an existing product, rather than that it has passed rigorous independent safety trials. In other words, specific testing on FDA Cleared products may be absent or minimal. There have even been cases when products are cleared because they are similar to previously cleared products, even when the older product was later recalled for safety reasons. Turns out the FDA is not perfect either, but is the best our federal government has to offer.
Other Marketing Terms You May Hear
The only two terms the FDA will use are FDA Approved and FDA Cleared. Everything else is suspect. I have seen websites with the FDA logo and words like “FDA Registered” and “FDA Certified.” These phrases should not make you feel that the product is safe. They are indicators that the manufacturer may be trying to deceive you.
Every company involved in the production or distribution of medical devices is required to register with the FDA. When a facility registers its establishment and lists its devices, the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices. So every medical company is FDA Registered. FDA Registered has nothing to do with the products they manufacture however.
FDA Product Registration Certificate
Additionally, The FDA does not issue any type of device registration certificates to medical device facilities. Any site that displays an official looking “FDA Registration Certificate” is suspect. These are fabrications by the seller and are not FDA certificates. The FDA has repeatedly called on firms to stop the production and distribution of these misleading certificates.
FDA Procedure Approval
Procedures are not approved, at least not yet. Only products can be approved.
Emergency Use Authorizations
In certain types of public health emergencies, such as during the COVID-19 pandemic, the FDA may issue an Emergency Use Authorization. When the Secretary of Health and Human Services declares that circumstances exist justifying the authorization of emergency use of medical devices, the FDA may issue an Emergency Use Authorization to authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met.
Emergency Use Authorizations can help provide more timely access to critical medical devices that may help during the emergency when there are no adequate, approved, and available options. This declaration also means that the products are not approved. If use is to be continued outside the emergency, approval will still be necessary following the normal approval process. The risk of not treating must be very high for untested products to get emergency use authorization.
The term FDA Approved is the gold standard for approval by the United States federal government. The organization is tasked with both making certain that products are safe and making sure that we have access to the latest advances needed to protect our health. Because it is a standard recognized around the world, it can be usurped to give unapproved products unwarranted credibility. As always caveat emptor – Let the buyer be aware. Knowledge is the key to success only when the knowledge is well vetted.Previous Post Next Post