by Gordon Needleman, Esq.

On May 28 1976 President Ford signed the Medical Device Amendments of 1976 (Amendments) to the Federal Food Drug and Cosmetic Act (FDCA) which substantially increase regulatory control of medical devices The Amendments are the first major Federal legislation concerning the regulation of medical devices since the FDCA of 1938 This article presents a summary of the background leading to the Amendments and 115 important provisions.

Background

The legislative history of the 1938 Act indicates it was intended to provide limited Food and Drug Administration (FDA) control over medical devices In 1938 most medical devices were of simple Construction and operation allowing health practitioners to easily determine if the devices were functioning properly Under the 1938 Act, the FDA functions were mainly surveillance and policing Tho policing was accomplished through the Federal Court system an expensive and time-consuming Process.