FDA Cleared Vs. FDA Approved

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The Food and Drug Administration (FDA) is responsible for the protection and overseeing of products that can affect public health. The FDA both clears and approves of items that fall under their umbrella of responsibility, from food and drugs to medical devices and tobacco products.


To get an item approved or cleared by the FDA, it must be submitted with an application. The two types of applications are a 510k, which is a premarket notification, and a premarket approval (PMA) application. Once these have been submitted and reviewed, the FDA can decide upon approving or clearing the drug or medical device.

Cleared Vs. Approved

Clearance requests are for medical devices that are exactly like those already on the market. Approved requests are for items that are completely new and need to be inspected for safety in case of new hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.


FDA approval or clearance is necessary to make sure patients using certain medical devices will be safe while utilizing the product. Devices go through rigorous study and examination before being allowed to be cleared or approved into the health care market. It also needs to be proven that the medical device will not only not do harm, but also that it will do good. The entire purpose of a medical device is to improve someone's health, and if the item does not pass that inspection, it will not receive clearance or approval by the FDA.