Medical Device Submission Types in US FDA
There are mainly 2 types of submission for medical device in FDA based on the classification. The classifications are based on intended use and indications, that is a risk-based classification. In FDA medical device is classified into class I, II and III. Class I devices has lesser risk than comparing to higher risk class III devices. Most of the class I devices and some of the class II devices are exempted from premarket Notification. The non-exempted devices in class I and II required 510(k) premarket notification. For Class III devices, a PMA (premarket approval) will be required.
- Class I – General Controls
- Class II – General Controls and Special Controls
- Class III – General Controls and Premarket Approval
The classification for the device can be determined by simply searching in FDA classification database. If you cannot determine the classification of your device, you can submit 513(g) classification requests to FDA. User fee is applicable for this service. Some NSE (not substantially equivalent) device which is not required PMA may be eligible for De Novo process.