Unless a medical device is 510(k) exempt, all medical devices must be cleared or approved by the FDA before it can be legally marketed.
- 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 involves a more rigorous review than the 510(k) review process as it covers Class III medical devices.
- Granted medical devices: This is a relatively new term in the FDA lexicon. Medical devices using the De Novo pathway must be Granted by FDA before they can be legally marketed in the US.
- Cleared medical devices: These medical devices are the ones that the FDA has determined to be substantially equivalent to similar legally marketed device. A manufacturer conducts a process called “Premarket Notification” or follows the 510(k) process to receive clearance from FDA.