How FDA Defines Substantial Equivalence to Predicate Devices

The concept of substantial equivalence of medical devices was introduced bythe US Food and Drug Administration (FDA) as part of the Medical DevicesAmendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act)enacted on May 28, 1976. The MDA gave the FDA authorization to issue regulations classifying all medicaldevices into three classes, based on … Continue reading How FDA Defines Substantial Equivalence to Predicate Devices