Premarket Approval (PMA)

Premarket Approval (PMA) is a stringent process required by the U.S. Food and Drug Administration (FDA) for certain high-risk medical devices before they can be sold. Manufacturers must provide extensive scientific evidence demonstrating that their product is safe and effective for its intended use. This includes results from clinical trials and detailed information about the device's design, manufacturing, and labeling. The PMA process ensures that new and innovative medical devices meet strict health standards, helping to protect patients and ensure quality in medical care.