Medical Device Submission Types in US FDA
There are mainly 2 types of submission for medical devices in the FDA based on the classification. The classifications are based on intended use and indications, a risk-based classification. The medical device is classified into classe I, II and III in the FDA. Class I devices have less risk than higher risk class III devices. Most class I and some class II devices are exempted from premarket notification. The non-exempted devices in class I and II required 510(k) premarket notification. A PMA (premarket approval) will be required for Class III devices.
- 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 the FDA classification database. If you cannot determine the classification of your device, you can submit 513(g) classification requests to FDA. The user fee is applicable for this service. Some NSE (not substantially equivalent) devices that are not required PMA may be eligible for the De Novo process.