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What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?

FDA-listed medical devices: A medical device is FDA-listed if the firm that manufactures or distributes the medical device has successfully completed an online listing for the device through the FDA Unified Registration and Listing System (FURLS). (While manufacturers are the entities that typically list medical devices, they are not the only entities responsible for doing so.)

510(k) exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered "510(k) exempt." These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness.

These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

Approved medical devices: Approved medical devices are those devices for which FDA has approved a premarket approval (PMA) application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a more rigorous premarket review than the 510(k) pathway.

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