What does the Medical Devices Act of 1976 classify devices into?

The Medical Devices Act of 1976 established a regulatory framework for categorizing medical devices based on the level of risk associated with their use. It divides devices into three main classes: Class I, Class II, and Class III. This classification system is primarily centered around the need for pre-market testing and regulation, with Class I devices being considered low risk and typically subject to less stringent controls, Class II devices requiring more regulatory scrutiny, and Class III devices, which are high-risk, requiring rigorous pre-market testing and approval.

This approach is designed to ensure that medical devices are safe and effective for their intended use while taking into account the potential risks they pose to patients. Understanding the classification system is crucial for compliance with regulatory requirements and for ensuring that appropriate testing and approval processes are followed for different types of medical devices.