Medical Device Amendments

The Medical Device Amendments (MDA) are regulations enacted in 1976 by the U.S. Congress to ensure the safety and effectiveness of medical devices. This law empowers the Food and Drug Administration (FDA) to oversee the approval and monitoring of medical devices, including everything from simple bandages to complex surgical instruments. The MDA establishes a framework for classifying devices based on their risk levels and mandates manufacturers to comply with specific standards for design, testing, and production. Overall, the amendments aim to protect public health by ensuring that medical devices are reliable and safe for patient use.