Coming Soon to the U.S. Federal Legislative History Library
When the Federal Food, Drug, and Cosmetics Act was passed in 1938, the FDA was charged with removing adulterated or mis-branded medical devices from the market. It did not however give the FDA the ability to review medical devices before they entered the market. When the Act was passed in 1938, medical devices were for the most part simple instruments in which defects could have been easily detected. Since then, technology and research has provided for the development of far more complex medical devices, many for which defects could not be and are not easily detectable.
From 1938 to 1976, hundreds of deaths and thousands of injuries were associated with defects in medical devices. As a result, the development and enactment of the Medical Device Amendments of 1976 was necessary. These amendments provided several mechanisms for the FDA to protect the public health from medical device flaws including classification of medical devices, device listing, establishment registration, adherence to Good Manufacturing Practices, and extensive control over devices prior to being introduced to the market. The 1976 amendments were even further refined with the Safe Medical Devices Act of 1990 and the Medical Devices Amendments of 1992 (the 1992 amendments are currently available in the U.S. Federal Legislative History Library ).
The 15-volume set covering the legislative history of the 1976 amendments and the 5-volume set covering the 1990 amendments will be both be available in HeinOnline's U.S. Federal Legislative History Library with the December content release.