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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report 2 Legislative History of the Medical Device Amendments of 1976 Peter Barton Hutt, senior counsel to the Washington, DC, law firm of Covington & Burling and former chief counsel (1971–1975) to the Food and Drug Administration (FDA), provided the committee with an overview of the legislative history of the Medical Device Amendments of 1976 (MDA). An inherent problem in a statute that requires premarket approval (PMA) is how to handle products that are already on the market on the date of enactment. Should the new requirements be imposed on the products already on the market, or should such products be given grandfather status? There were three precedents to consider in drafting of the 1976 amendments, Hutt said. The Food Additive Amendments of 1958 stated that all food additives on the market on the date of enactment had 3 years, until 1961, to obtain FDA approval. That was unrealistic for both industry and FDA to comply with, Hutt noted. The FDA of the late 1950s was a small organization with a budget of less than $70 million. Congress ultimately had to pass two additional laws to extend the time. But it was clear that a model of that type was not appropriate for drafting the MDA. The second precedent was the Color Additive Amendments of 1960, which gave industry 2.5 years to get approval for their color additives that were already on the market but allowed FDA to extend that time without limit. There are still color additives on the market that have not been approved. Giving extensions in perpetuity did not appear to be a workable solution to the problem. Finally, the Drug Amendments of 1962 mandated that a new drug be proved effective as well as safe to gain approval. Drugs that were on the market before the amendment either were grandfathered (that is, considered
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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-Unidisk Company 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
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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
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report Paul Rogers for food and drug law matters; Rod Munsey, representing the Pharmaceutical Manufacturers Association; and Hutt, representing FDA, then spent 2 months totally rewriting the statute. At the time, Hutt noted, 13 trade associations represented the medical device industry and requested an opportunity for input; these ultimately assembled into what is now the Advanced Medical Technology Association, or AdvaMed. In the draft that would become the MDA, the issue of classification was separated from the issue of how a device gets to market. Hutt noted that calling this the 510(k) process is something of a misnomer in that it is actually Section 513 of the Federal Food, Drug, and Cosmetic Act that requires FDA to classify medical devices as class I, II, or III on the basis of potential risks and benefits. Section 510(k) was written as a reporting obligation. FDA had no authority to approve a 510(k) submission. Until 1990, when the law was changed, a manufacturer merely submitted a 510(k) report to FDA and placed its product on the market. The original objective was for FDA to have knowledge of all devices on the market so the Agency could prioritize and determine the appropriate classification and requirements. The legislation stated that a postamendment device could be marketed if it was not “significantly different” from an existing device. There were no deadlines in the standard provisions for devices that needed to be approved and no time limit for FDA to review preamendment devices. That gave discretion to FDA throughout the statute by using general terms. A banned-device provision was included to ensure FDA’s authority to put a notice in the Federal Register and remove a product from the market. There is adequate authority for FDA to require reports from the industry about adverse events resulting from use of their devices. (In response to a committee question, Hutt added that although it was not feasible then, it would be realistic now to set up a broad national system that would link databases of institutions that use medical devices.) The drafters’ intent was that FDA would actively set priorities and potentially revise what was considered a reasonable model for substantial equivalence as it went along rather than necessarily becoming passive and allowing things to continue with no end in sight. After the bill was introduced in March 1973, it was decided that not significantly different was not ideal, and substantially equivalent was included in the final legislation. The MDA was enacted in 1976.