Pre-Market Approval (PMA)

Pre-Market Approval (PMA) is the process through which the U.S. Food and Drug Administration (FDA) evaluates the safety and effectiveness of new medical devices before they can be sold to the public. Manufacturers must submit detailed data from clinical studies and testing to demonstrate that the device works and is safe for its intended use. The FDA reviews this information thoroughly and, if everything meets standards, grants approval. PMA helps ensure that medical devices are reliable and safe for patients, balancing innovation with public health protection.