. "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
would be subject to performance review (similar to what is now referred to as PMA). The report did not address how to apply the new requirements to products that were already on the market, but it unequivocally established the proposition that devices, which are continually modified, are not drugs. Although it was not called this at the time, it was a risk-based statute that assigned devices to high-risk, medium-risk, and low-risk categories.
In 1970–1976, the Senate Committee on Labor and Public Welfare, chaired by Edward M. Kennedy, introduced medical device legislation and twice passed it. The Senate bill had a provision that would have required PMA only when FDA issued a regulation. It solved the problem of pre-amendment and postamendment devices by saying that no manufacturer had to seek PMA for a device until every device in the same class of device had to be approved. If a device was already on the market, the manufacturer would have up to 5 years to get a PMA application approved. Again, the hard deadline of 5 years was of concern in light of how few resources FDA had to meet the deadline. In addition, the provision granted a 5-year monopoly to preamendment devices.
Legislation was introduced in 1971 and again in 1973 by Harley Staggers, chairman of the House Interstate and Foreign Commerce Committee. Among its deficiencies, it did not provide for FDA taking an inventory of all devices and did not provide for classification of devices.
The Health Subcommittee of the House Committee on Interstate and Foreign Commerce, chaired by Paul G. Rogers, drafted and introduced a bill 1 month after the Cooper Committee report was released in 1970 and then drafted and introduced bills in 1971, 1973, 1975, and 1976. The initial House bills of 1970 and 1971 defined class I as everything that was GRAS and GRAE. The use of GRAS and GRAE were of concern because as a result of their inclusion in the 1958 Food Additive Amendments and the 1962 Drug Amendments, companies went ahead and marketed their products as safe and effective, and then FDA would have to bring legal action in the courts to take them off the market. Class II at that time was subject to standards (now called special controls) that applied to both preamendment and postamendment devices. Class II was essentially a buffer, a place for devices that are halfway between those requiring general controls and those requiring PMA. For Class III, the House bill was comparable with the Senate bill, giving manufacturers of preamendment devices 30 months, which could be extended to 60 months, to get PMA.
Later, Hutt (then chief counsel for FDA), Charles Edwards, and Alexander Schmidt established an inventory of some 8,000 devices that were on the market, set up classification panels, and established the Bureau of Medical Devices in FDA. Those technically unauthorized actions drew the attention of the House, as intended. David Meade, of the Office of Legislative Counsel in the House of Representatives; Steve Lawton, assistant to