The Difference Between FDA Cleared and FDA Approved
What's the difference between FDA cleared and FDA approved? You may have seen these terms attached to numerous medical products and wondered what each classification represents. This guide reviews the differences between them along with the process that medicines and medical devices go through before they can be prescribed by doctors or marketed to the public.
Here is what we'll cover today:
- What is the FDA?
- What Does FDA Approved Mean?
- FDA Registration
- FDA Clearances: What Does FDA Cleared Mean?
- CES is FDA Cleared
- Frequently Asked Questions
- FDA Cleared vs Approved: the Takeaway
What is the FDA?
The FDA is the Food and Drug Administration. It's responsible for protecting consumers in the United States from potentially unsafe medical products and foods. Some cosmetic products and most veterinary medicines are also regulated by the FDA. Theodore Roosevelt helped create the FDA by signing the Food and Drugs Act into law in 1906, and its regulatory powers were expanded in 1938 by Franklin Roosevelt.
The original purpose of the FDA was to protect America's food supply because many businesses used harmful chemicals to extend the shelf life of foods on store shelves. Later laws allowed the FDA to act against false claims made by pharmaceutical companies about the efficacy of their drugs. Today, the FDA works with food and drug companies to ensure consumers are only sold products that are deemed safe and effective.
During the pandemic, the FDA granted emergency approval for the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines, which is another function of the administration. When it serves the public good, the FDA can grant approval for some products to make it to the market that may have needed to undergo years of trials and research. Once some treatments and medical devices are considered safe enough for approval, the FDA can also clear related products that provide similar benefits.
What Does "FDA Approved" Mean?
Before new drugs and medical devices can be placed on the market, they must undergo pre-market approval from the FDA. People often confuse the meaning of an approval as an endorsement, but the FDA doesn't endorse or back any of the companies or products that it regulates. Medical products need to meet certain quality control standards before they can be mass-produced and sold across multiple states.
Approval means that the FDA believes that the medication or medical device it has approved offers more of a benefit to consumers than the potential risks. That doesn't mean that products approved by the FDA don't have side effects and/or aren't risky. There have been cases in which the FDA has issued alerts and warnings years after an approval, usually when new evidence suggests that a product may be harmful or is being prescribed for the wrong uses.
None of the products that the FDA approves have actually been tested or developed by the administration. They review the case studies provided by the manufacturer to determine whether it's considered safe. The FDA does, however, use a tiered classification system to communicate how much risk a product has and whether it needs to be regulated.
For example, Class I products have the lowest risk and usually don't require much oversight. Class III products are controlled substances and medical devices, which can only be prescribed and used under the direct care and supervision of a physician. Class II devices are in the middle and have only a moderate risk. The words "FDA approved" can be quite misleading for these reasons.
Businesses that market medical products must register themselves with the FDA so that the government is aware of the types of products they sell. Registration is renewed each year, so for a company to continue producing medications or manufacturing medical devices, it must register with the FDA again each year. When a company states that it's registered with the FDA, it simply means that it filed the proper paperwork to be recognized as a company doing business in their field.
Companies must provide the FDA with a complete list of all of the things they produce and sell each year. Aside from tracking what a business is doing, this doesn't mean much else.
FDA Clearances: What Does FDA Cleared Mean?
Let's go back to the beginning. What's the difference between FDA cleared and FDA approved? If a new, innovative drug, vaccine or medical device is approved by the FDA and helps a lot of people, other companies may be able to produce similar products that offer the same features and work in a similar way.
One great example is blood glucose monitors. There are many products available to diabetics that help them check their glucose levels throughout the day, enabling them to tell whether they're taking enough insulin or if they're experiencing hypoglycemia. Since a similar product already gained FDA approval in the past, a new one might receive clearance from the FDA because the manufacturer can prove it works much like the competitor's product does.
There are many types of medical devices on the market that are similar to one another. Rather than force each new manufacturer to perform their own case studies to show that their devices address a medical concern, they only need to prove that their products work as well as the ones already available.
CES is FDA Cleared, Not Approved
Cranial electrotherapy stimulation (CES) devices have been cleared by the FDA as Class II medical devices for anxiety and insomnia, but remain Class III for depression. They were recently downgraded from Class III to Class II after the FDA determined that they pose only a moderate risk to users. While CES devices aren't approved for the treatment of medical conditions by the FDA, they may help people manage symptoms of conditions such as anxiety, depression, ADHD, addiction, insomnia, chronic pain and more.
You should speak with your doctor about which CES device is best to manage your specific symptoms before you decide on one that's right for you. For example, the MindGear CES device is FDA cleared to help people manage the symptoms of anxiety and insomnia. The ideal device for you depends on your personal preferences and what you're using it for.
Frequently Asked Questions
What is FDA 510k Clearance?
FDA 510k clearance is the process that businesses go through to gain permission to market their drugs or devices to the general public. The 510k clearance process is for medications and devices that are similar to those that have already made it to the market. Most FDA cleared devices have demonstrated that they provide more benefits for the consumer than the potential for harm.
Does “FDA cleared” mean anything?
FDA cleared means that a product is considered safe to use, but it doesn't mean that the organization backs any of the manufacturer's medical claims. The FDA only clears products that meet certain quality and safety standards. Therefore, if a product is cleared, you can have confidence that it doesn't pose a significant chance of harming you.
Is FDA registered and FDA approved the same thing?
Be careful of products that are marketed as FDA registered without approval or clearance. "FDA approved" is also a highly misleading term because it only means that the product is considered safe for use. It doesn't mean that the product is proven to treat or “cure” any medical condition. It might help people manage symptoms.
FDA Cleared vs Approved: the Takeaway
Just because a product is marketed as "FDA approved" doesn't mean that it's considered a medical treatment or cure for a condition. FDA approval and clearance is given to products that are safe to use and the tier reveals how risky a product is in the eyes of the organization. Always discuss your treatment options with a physician who can monitor your progress and provide professional, informed advice.
CES devices are FDA cleared to help many people manage symptoms ranging from insomnia to anxiety, addiction or chronic pain. Caputron has a wide selection of these available that you can choose from. Find the best CES device for your circumstances today.
Do you still have questions about neuromodulation devices, or do you need help to decide which one is best for you? Contact one of our neuromodulation experts.