In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
