US FDA Medical Device Classification

The US Food and Drug Administration (FDA) classified medical devices depending on the risk they pose to the user. The FDA divides devices into three classes: Class I (low risk), Class II (moderate risk), and Class III (high risk) (high risk). In addition, the device’s intended function, the location within the patient where it will be utilised, the duration of engagement with the patient, and whether the device is active or passive are all factors that influence FDA medical device classification.

Class 1 devices must be developed and manufactured in accordance with “general controls,” such as having appropriate labelling or branding that is not deceptive, the manufacturing establishment must be registered with the FDA, effective manufacturing controls (GMP) must be in place.
Outside of the permitted “exemptions,” Class II and Class I devices must go through the 510(K) clearance to the market approval process. Class II devices are subject to “special controls,” such as labelling and post-market surveillance. “Good manufacturing practises” should be followed while producing Class II devices
The PMA (pre-market approval) process will be required for Class III devices. Note: There are certain exceptions to the whole PMA approval process, such as if the device is substantially comparable to one that was on the market before 1976 and did not require a PMA previously.

FDA Classification and Regulatory Controls

FDA Medical Device Classification Flow Chart

If you need to file a premarket notification [510(k)] for your device, go to the [510(k)] Premarket Notification
Proceed with registration and listing for Class I devices exempt from 510k, or (or some class II) devices are exempt from the 510(k) procedure, subject to the restrictions on exemptions, as specified in the classification rule. Other General Controls, however, apply, such as registration and listing, labelling, and good manufacturing standards.
Proceed to the Premarket Approval (PMA) page if you have a Class III device that requires premarket approval (PMA).