. "2 Legislative History of the Medical Device Amendments of 1976." Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press, 2010.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report
not to be new drugs that needed approval) or could remain on the market until FDA reviewed them and made decisions about their efficacy. FDA had to review 8,000 new drug applications for pre-1962 drugs. Now, 48 years later, there are still 20 products whose status has not yet been resolved.
On May 13, 1962, President Kennedy introduced two pieces of legislation in Congress: one that ultimately became the Drug Amendments of 1962 and one that dealt with new device applications and new cosmetic applications. The device legislation essentially applied the entire system of new-drug regulation to medical devices. Any device that was generally recognized as safe (GRAS) and generally recognized as effective (GRAE) was exempted. The bill provided 18 months, which FDA could extend to 30 months, for all pre-existing devices to be approved. That approach was unworkable, Hutt said, and would have been similar to the food additive approach in which neither industry nor FDA could realistically comply with the timelines. Needing to respond to the thalidomide disaster, however, Congress focused only on passage of the drug bill and said that it would enact medical device legislation in the following year. It took 14 more years to enact medical device legislation.
From 1962 to 1969, every president of the United States, in major addresses to Congress, endorsed medical device legislation. Bills were introduced with every kind of approach to the question of preamendment devices on the market and postamendment medical devices coming onto the market, but none of the bills came close to enactment, Hutt said.
In 1969, the Supreme Court issued a decision in the Bacto-UnidiskCompany case that said that an antibiotic-sensitivity disc (a laboratory tool used to determine whether cultures of bacteria are sensitive to particular antibiotics—a product that does not ever touch the human body) was a drug. The Supreme Court decision stated that FDA did not have adequate device legislation and so the Court was expanding the concept of a drug so that the agency could require new drug applications for diagnostic products and other important medical items.
That meant either that FDA was going to go forward and designate whatever devices it deemed necessary as drugs or that Congress needed to approve new device legislation. President Nixon, in a message to Congress, ordered that the matter be reviewed by a committee to be established by the Department of Health, Education, and Welfare. Ted Cooper, who was the director of what is now the National Heart, Lung, and Blood Institute of the National Institutes of Health, was chosen to chair the committee. In September 1970, the “Cooper Committee report” was issued. It recommended creation of three classes of medical devices on the basis of the amount of regulation necessary for each class; the first class would be exempt from standards or premarket clearance (subject only to general controls), the second would require controls through the use of standards, and the third