ZQuiet

What is the difference between FDA clearance and FDA approval?

By Gorilla Web | September 12, 2016 | Additional Information

ZQuiet® is FDA cleared to treat snoring. All oral anti-snoring devices are considered Class II medical devices regulated by the FDA and must meet their requirements. Technically, if a similar device with the same indicated use exists, the FDA does not “approve” a new device in the same category; they “clear” them for sale under the 510(k) Clearance process. In order to receive FDA Clearance, a product must be proven effective and must also undergo very strict consumer safety testing. There are many anti-snoring devices sold online that are not cleared by the FDA, and there is no way to ensure that those products are effective or safe for consumers, or legal for sale.