US FDA Medical Device Classification

The US Food and Drug Administration (FDA) device classification system is one of the world’s most complex, with 16 review panels; more than 6,500 product codes; approximately 1,700 regulation numbers; and devices identified as unclassified, Class I, Class II, Class III, not classified, and Humanitarian Device Exemption (HDE).  

There are also eight routes to commercialization in the US: 510(k) exempt, 510(k), De Novo, premarket approval, HDE, emergency use authorization, enforcement discretion, and contact the Office of Device Evaluation.  

The first step in developing a successful regulatory strategy to commercialize your device in the US is understanding its classification. While many devices are easy to classify, others are not. Many device classifications require careful evaluation before proceeding with a regulatory submission to the FDA. Emergo by UL can assist you in classifying your medical device or help you contact the FDA for assistance under their 513(g) Request for Information (classification) process.