FDA’s 515 Program Initiative

• Date: January 26, 2011
• Source: Admin

FDA regulates medical devices and places them under one of the three classes, viz., Class I, Class II and Class III, based on the level of risk they carry. Class I and Class II devices are generally regarded as low-risk devices. They require FDA Clearance of an application called Premarket Notification ((or 510(k)) if the device is to be permitted to be sold in US. Class III devices, which tend to be high-risk devices and first-of-a-kind devices, require FDA Approval in the form of a Premarket Approval (PMA) Application.