The concept of substantial equivalence of medical devices was introduced by
the US Food and Drug Administration (FDA) as part of the Medical Devices
Amendment (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 medical
devices into three classes, based on the level of controls they deemed necessary
to provide reasonable assurance of their safety and effectiveness


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