FDA Approved vs FDA Cleared

On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does not approve all products in the categories above...

1. FDA Approved vs FDA Cleared
By: Nikita Angane, MS

On numerous occasions, we have seen companies’ websites and products boasting with an FDA
approved stamp on it. While the FDA is responsible for protecting public health by regulating
drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does not
approve all products in the categories above.
Here are some things to keep in mind while looking for FDA approved vs FDA cleared
products:
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1. FDA does not approve companies.
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FDA does not provide any kind of approval declaration for any manufacturing, healthcare or
laboratory facilities. However, these facilities are required by law to follow standard quality
practices and FDA has an authority to inspect these facilities. Owners and operators of most
medical devices need to only register their facility with the FDA.

2. FDA approves class III and humanitarian use devices.
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Class III devices are the ones classified to be with high risk to public health; while humanitarian
use devices are devices that are used to treat conditions/disorders that affect less than 8000
people per year and are subject to a separate approval process called HDE (Humanitarian Device
Exemption). All implantable devices fall under the class III category and receive an FDA
approval by demonstrating with sufficient, valid and scientific evidence that the devices are safe
and effective for the intended use.

3. FDA generally clears class II devices.
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Moderate risk medical devices are categorized as Class II. These devices are generally cleared
for marketing once they demonstrate that the device is substantially equivalent to a legally
marketed predicate device.
Low-risk devices such as bandages, exam gloves are classified as class I devices and most of
them are exempt from even submitting a premarket notification.

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4. FDA approves new drugs and biologics.
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New drugs and biologics must be proven safe and effective before companies can market them.
The manufacturing process at these facilities must also follow quality practices. FDA reviews the
results submitted within the application packet by the company but does not perform any tests on
its own. If the FDA grants approval to the drug or biologic, it means that the benefits of the
product outweigh the known risks.
Always be aware of what you claim on your product labeling, packaging or on your website. If
you need help or guidance, or if you have any questions, reach out to us at 248-987-4497 or
email us at [email protected].


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FDA (January 2017) Is It Really 'FDA Approved?' retrieved on 05/06/2019 from
https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved