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.
Taylor Lunsford is a Regulatory Affairs Associate from Houston, Texas and holds degrees from the University of Houston and the Defense Language Institute. Before working with Proxima, he served in the Army as a Mandarin Chinese translator and intelligence analyst.
