Lexology April 22, 2022
In the United States, the U.S. Food and Drug Administration (FDA) regulates the production and sale of medical devices. The FDA releases rules regarding classification, registration, premarket approval, product labeling requirements, and quality controls for medical devices.
The FDA regulations apply to devices manufactured in the U.S. as well as imported medical devices. The Center for Devices and Radiological Health (CDRH), a branch of the FDA, oversees implementing regulations for the production and sale of medical devices in the U.S. as well as the safety and performance of these devices.
Congress passed the Food, Drug, and Cosmetics Act (FDCA) in 1938. The FDCA gives the FDA the authority to enact regulations impacting the production and sale of medical devices in...