What are the classifications of medical devices?
A device must undergo several stages of development and testing before it is eligible for approval from the FDA. There are three levels of medical devices: Level I & II – These devices are not considered high risk but must be compared to an existing device to determine equivalence. These devices must receive pre-market notification before use in clinical trials. Level III – Level III devices are considered high risk devices. Before Pre-Market Approval can be issued, clinical data must be presented to determine the level of risk. Only acceptable risk devices are approved. Some medical devices fall under IDE (Investigational Device Exemption) which are unapproved. If the device is classified as posing a significant risk in a clinical trial, then FDA approval is needed to proceed with testing. If the device does not pose a significant risk, IRB approval is required . If favorable results are seen based on clinical trials, the sponsor may submit the device to the FDA for approval. The devi
