Info FDA- Listed, 510(k) Exempt, Cleared, Approved, Medical Devices
According to the U.S. Food and Drug Administration (FDA) you should understand the hereafter stated indications, as follows:
FDA-listedA medical device is FDA-listed when the manufacturer or distributor successfully completed an online listing for the device through the FDA Unified Registration and Listing System (FURLS).
FDA-510(k) exemptA medical device is considered FDA-510(k) exempt, when a FDA review is not required. This mainly concerns low risk medical devices also known as Class I and sometimes Class II. It has been determined that these devices don't need a 510(k) premarket notification.
However, these medical devices have to comply with - as stated bij the FDA:
- suitable for their intended use
- adequately packaged and properly labeled
- establishment registration and device listing forms on file with FDA
- manufactured under a quality system
Examples of exemptions are:
- air-conduction hearing aid
- hot or cold disposable pack
- powered heating pad
FDA-clearedA medical device is FDA-cleared when the new device is substantially equivalent to another legally marketed device.
Therefore the FDA reviews a 510(k) premarket notification that has been filed with the FDA. (510(k) is section in Food, Drugs and Cosmetic Act).
The 510(k) notification form - to be submitted by the manufacturer or distributor - should contain specifications of the new medical device and an equivalent already legally marketed device, so FDA can then determine that the new device is substantially equivalent to the other device.
The FDA does not actually inspect and/or testing the device.
Examples of cleared medical devices are:
LightStim for wrinkles (FDA-clearance number K120775)
FDA-approvedA medical device is FDA-approved when the FDA has reviewed a PreMarket Approval (PMA) application, submitted to the FDA and before the device can be marketed.
This PMA procedure is usually for high-risk devices.
The applicant who want approval, must give reasonable assurance of the device's safety and effectiveness.