Medical Device Regulation Comes of Age
The Limitations of FDA Authority
As we saw in chapter 2, the FDA had very limited powers over medical devices under the 1938 Food, Drug, and Cosmetic Act. Its primary authority was seizure of individual devices found to be adulterated or misbranded. Most of the FDA's early enforcement
activity was directed toward controlling obvious quack devices. However, even this limited regulatory activity declined during World War II. Because of the scarcity of metals and other critical materials, production of nonessential devices was restricted, and consequently the pace of seizures and prosecutions dropped to less than six per year.[1]
House Committee on Government Operations, Hearings on Regulation of Medical Devices (Intrauterine Contraceptive Devices), 93rd Cong., 1st sess. (Washington, D.C.: GPO, 1973), 180.
After World War II, there was an increase in device quackery because of the cheap availability of war surplus electrical and electronic equipment.[2]
Davidson, "Preventive 'Medicine' for Medical Devices: Is Further Regulation Required?" Marquette Law Review 55 (Fall 1972): 423-424.
A variety of products that used dangerous gases (such as ozone and chlorine), radio waves, heat, and massage were marketed for the treatment of almost every disease known. Among the most dangerous were quack devices that used radium, uranium ore, and other radioactive substances and that purported to cure common problems such as sinus infections and arthritis.The pace of FDA seizures picked up in response. In a report in 1963, the Bureau of Enforcement of the FDA's Device Division stated that from 1961 to 1963, the FDA seized 111 different types of misbranded or worthless devices, involving 15,070 individual units. Fifty-four diagnostic and treatment devices were taken in 358 seizure actions from June 1962 to June 1963.[3]
Milstead, 1963 Congress on Quackery, 30.
Some states tried to tackle the problem with their own legislation. For example, California had passed a state Pure Foods and Drug Act in 1907, one year after the first federal act. The law prohibited any claim for a food, drug, or device that was false or misleading in any particular. California brought over sixty court actions from 1948 to 1957. The focus of this early activity was on fraudulent devices; concern about the safety of clearly therapeutic products came later.[4]Ibid.
Congressional legislative activity focused on drug risks in the late 1960s. Congress increased FDA power to regulate drugs in 1962 in response to controversial evidence linking birth defects and the drug thalidomide.[5]
Temin, Taking Your Medicine, 123-126.
The 1962 amendments to the Food, Drug, and Cosmetic Act greatly strengthened federal power over drugs by requiring proof that the product was both safe and efficacious before it received FDA marketing approval. Because of the previous distinction between drugs and devices made in the 1938 law, these expanded powers did not apply to new medical devices.[6]See discussion in chapter 2.
By the late 1960s, problems associated with legitimate, therapeutically desirable medical devices that were flooding the marketplace began to surface. In 1970, Dr. Theodore Cooper, then director of the NIH Heart and Lung Institute, completed a survey of the previous ten years that revealed 10,000 injuries from medical devices, including 731 deaths. Defective heart valves caused 512 of the deaths.[7]
U.S. Department of Health, Education, and Welfare, Cooper Committee, Medical Devices: A Legislative Plan, Study Group on Medical Devices (Washington, D.C.: GPO, 1970). Cited and discussed in Medical Device Amendments of 1975, Hearings on H.R. 5545, H.R. 974, and S. 510 Before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, statement of Rep. Fred B. Rooney, 94th Cong., 1st sess., 199. See also Theodore Cooper, "Device Legislation," Food, Drug, Cosmetic Law Journal 26 (April 1971): 165-172. There have been challenges to the data in the Cooper report, but the public attention the study received made the issue of device safety politically salient.
In particular, problems had arisen involving defective pacemakers[8]U.S. Comptroller General, Food and Drug Administration's Investigation of Defective Cardiac Pacemakers Recalled by the General Electric Company 21 (1975). GE decided to voluntarily recall over 22,000 pacemakers because some malfunctioned due to moisture that seeped into the pacemaker circuitry, probably due to faulty seals.
and intrauterine devices.[9]See discussion in this section.
Congress, the FDA, and the public became concerned.Creative Regulation by the FDA
The increase in legitimate medical devices complicated the FDA's regulatory efforts. The sophisticated new technologies, such as pacemakers, kidney dialysis units, cardiac, renal, and other catheters, surgical implants, and diagnostic instruments, challenged the FDA's expertise. The agency's regulatory power was limited to seizure of products already on the market. In order to bring a seizure action under the law, the FDA had to consult experts, sponsor research, and gather data to meet its statutory burden of proof in court. The real problem was that seizures were simply not a reasonable response to devices that had benefits as well as risks. The goal was not to remove these products from the market as much as to ensure that these innovations were safe.
In the absence of additional authority, the FDA began to implement the law more aggressively. One tactic was to construe the statutory definition of drug broadly enough to include products that were clearly medical devices and thus would allow the agency to regulate devices much as it regulated drugs.
Device companies challenged this effort to impose drug regulation on devices. Two important court decisions in the late 1960s upheld the FDA's broad reading of the term drug . In AMP v. Gardner , the court reviewed the FDA's classification as a "new drug" a nylon binding device used to tie off severed blood vessels during surgery.[10]
389 F.2d 825 (2d Cir. 1968).
The court broadly construed the purpose of the 1938 act and the 1962 amendments, holding that the goal was to keep inadequately tested and potentially harmful "medical products" out of interstate commerce. Emphasizing the protectivepurposes of the law enabled the government to regulate as a drug any product not generally recognized as safe.
The next year, the Supreme Court followed similar reasoning in United States v. An Article of Drug … Bacto-Unidisk .[11]
394 U.S. 784 (1969).
In 1960, after the product had been in use for four years, the secretary of HEW classified an antibiotic disk as a drug. The product, which never came into contact with the human body and was therefore not metabolized, was used as a screening test in a laboratory to determine the proper antibiotic to administer. Its classification as a drug came after the agency received numerous complaints from the medical profession, hospitals, and laboratory technicians that the statements of potency for the disks were unreliable. The FDA found it "vital for the protection of public health" to adopt the regulations.[12]25 Federal Register 9370 (30 September 1960).
The Court, acknowledging that the FDA was an expert agency charged with the enforcement of remedial regulation, deferred to the secretary's medical judgment. It concluded that the term drug was a legal term of art for purposes of the law, which was a broader interpretation than the strict medical definition. The Court determined that the parallel definitions of drugs and devices, discussed previously, was "semantic." Concluding that there was no "practical significance to the distinction" until subsequent amendments to the 1938 Act, the Court gave the term "a liberal construction consistent with the act's overriding purpose to protect public health."[13]
394 U.S. 784, 798 (1969).
IUDs
The FDA's response to problems associated with implanted intrauterine devices illustrates its efforts to regulate creatively to protect the public. IUDs to prevent pregnancy had been available since the turn of the century. Although they had been generally dismissed as dangerous by respectable practitioners, the technology began to be reevaluated in the late 1950s. The renewed interest in contraceptives, the availability of inert plastics that caused fewer tissue reactions, and the growing controversies about the safety of the new contraceptive pills all encouraged research on IUDs.
IUD devices began to enter the market in the mid-1960s.
From 1969 to the early 1970s, IUD use skyrocketed. By the end of 1970, three million women in the United States had been fitted with a variety of IUD devices. Marketing was aggressive, and the competition among firms was keen. The top sellers included Ortho Pharmaceutical's Lippes Loop, the Saf-T-Coil produced by Schmidt Labs, and the now infamous Dalkon Shield introduced by A. H. Robins in January 1971.[14]
The Dalkon Shield claimed to be superior to other products because of its unique shape. The nature of the product and the harms related to its design are discussed more fully in chapter 6.
G. D. Searle entered the market in the same year with the Cu-7, a device shaped like the number 7 with a small thread of copper wound around the vertical arm, which the company claimed increased the product's efficacy. The data regarding unit sales testify to the early success of these products (see table 6).Despite burgeoning sales, product safety remained a concern. As early as 1968, an FDA advisory committee on obstetrics and gynecology cited significant injuries and some deaths associated with IUDs.[15]
House Hearings on Medical Devices, Advisory Committee on Obstetrics and Gynecology of the Food and Drug Administration, Report on Intrauterine Contraceptive Devices (1968), 441.
The devices generated numerous complaints, and there were reports of infections, sterility, and, on some occasions, death.Under the device provisions of the 1938 law, the FDA had only the limited power to seize individual products, an impractical remedy in this situation. An internal FDA memorandum recommended that the AMP v. Gardner precedent be used to designate all products intended for prolonged internal use to be considered "drugs" for purposes of premarket approval.[16]
House Hearings on Regulation of Medical Devices, memorandum of William Goodrich, assistant general counsel of the FDA, 19 March 1968, 205-206.
If this recommendation had been adopted, all implanted devices, including pacemakers and IUDs, would have been officially considered drugs under the law.The agency did not go so far. In 1971 it considered a proposed rule on the classification of IUDs. At that time, G. D. Searle began to market the Cu-7 IUD. Because this device contained a noninert substance, the FDA's final rule in 1973 distinguished between device-type IUDs and drug IUDs. The agency treated as a regulated drug any IUD that contained heavy metals or any substance that might be biologically active in the body. An IUD was a device, hence exempt from premarket approval requirements, if it was fabricated entirely from inactive materials or if substances "added to improve the physical characteristics [did] not contribute to contraception through chemical action on or within the body."[17]
44 Federal Register 6173 (31 January 1979).
Thus, Searle's Cu-7 was subjected
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to premarket approval, as was Progestasert, an IUD with a timed-release contraceptive hormone that entered the market in 1976.
FDA officials later admitted the frustration of using the drug provisions as a substitute for adequate device regulation. Despite efforts to increase the staff for the Medical Devices Program, the agency had limited resources for the regulation of devices as drugs.[18]
House Hearings on Regulation of Medical Devices, 183.
Other important jurisdictional issues arose as well. In 1972, Peter Barton Hutt, general counsel for the FDA, said that "The administrative burden of handling all devices under the new drug provisions of the act would be overwhelming…. If we were to reclassify all devices as new drugs, difficult legal issues would be raised about our authority to allow them to remain on the market pending approval of an NDA [new drug approval]. Wholesale removal of marketed products would, of course, not be medically warranted."[19]House Hearings on Regulation of Medical Devices, statement of Peter Barton Hutt, 209.
Without clear legislative authority, the FDA was unwilling to regulate devices through use of the provisions intended to apply only to drugs.As might be expected, problems related to devices continued to arise. When reports of severe adverse reactions were specifically associated with the Dalkon Shield, an advisor to the FDA recommended that it be removed from the market. The big question was how to do so under the law. The only power the FDA had was to get a court injunction to halt interstate shipments of adulterated and misbranded products and to proceed to seize them one at a time. Of course, for implanted products, safety would clearly be better served by preventing these products from entering the market in the first place. A. H. Robins finally admitted the inevitability of some government action,
and, in the wake of significant adverse publicity, the company voluntarily suspended sales, pending a hearing of FDA advisory bodies. The product never returned to the market.[20]
Enter policy proliferation. The company's action may well have been motivated primarily by the fear of lawsuits, not the fear of FDA action. In any event, the FDA had few powers to invoke. Issues relating to product liability will be discussed in chapter 6.
The FDA ultimately got the outcome it desired, but its formal regulatory impotence did not go unnoticed by Congress or the public.Congress Takes Action
The limited powers of the FDA had been graphically demonstrated during the Dalkon Shield controversy. Congress not only was aware of the publicity concerning harmful devices but also had held hearings on several products during this period.[21]
Pacemaker hearings, medical device (IUD) hearings.
Bills to expand the FDA's authority over devices had been introduced every year from 1969 to 1975. The likelihood of congressional action was increased by the fact that consumer activism was at its peak. The controversies surrounding IUDs mobilized the nascent women's movement, and defective cardiac pacemakers caused concern among the elderly. Ralph Nader's Health Research Group vigorously lobbied government to protect consumers in the areas of medicine and health products.On the other side, the medical device industry was not well organized. Until this time, government had been either neutral or a benefactor, not a threat to the industry's well-being. In fact, there was no trade association until the mid-1970s. Unlike the drug industry, which was represented by the old and powerful Pharmaceutical Manufacturers Association (PMA), the device producers were a disparate group with no clearly identifiable or shared issues. Many were small innovators with little or no experience with the political process.
The prospect of regulation spurred organizing efforts. The Health Industry Manufacturers Association (HIMA) formed in 1976, but it was too late to stop Congress from regulating the industry. Indeed, the organization was established in direct response to the new regulatory threat. Some larger device companies had their own Washington offices that handled government relations; for smaller companies, HIMA was the only representation. HIMA has since become larger and more active, but in the 1970s members of the industry were reactive, not proactive. Regulation was only a matter of time.
The Medical Device Amendments of 1976
The Medical Device Amendments of 1976 sought to provide "reasonable assurance of safety and effectiveness' for all devices.[22]
Public Law 94-295, 90 Stat. 539 (1976) codified at 21 United States Code secs. 360c-360k (1982), (a)(1-3). For detailed discussion of the Medical Device Amendments, see Foote, "Loops and Loopholes"; David A. Kessler, Stuart M. Pape, and David N. Sundwall, "The Federal Regulation of Medical Devices," New England Journal of Medicine 317 (6 August 1987): 357-366; and Jonathan S. Kahan, "The Evolution of FDA Regulation of New Medical Device Technology and Product Applications," Food, Drug, Cosmetic Law Journal 41 (1986): 207-214.
The FDA was to determine whether such assurance existed by "weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." The law conferred powers upon the FDA to regulate medical devices during all phases of development, testing, production, distribution, and use.In order to accomplish these goals, Congress devised a complicated regulatory scheme. This complexity arose from both the diversity of the products to be regulated and the lack of trust between Congress and the FDA at that time. The diversity of devices dictated a regulatory system that would provide levels of government scrutiny appropriate to the nature of each device. The lack of trust meant that Congress did not give the agency discretion to implement the law; instead, detailed provisions were intended to force the agency to regulate with vigor.[23]
See letter from Representative Paul Rogers, one of the authors of the legislation to Alexander Schmidt, commissioner of the FDA, 21 June 1976 (cited in Foote, "Administrative Preemption," 1446, n. 74).
In the law, Congress used two different methods to group medical devices: first, devices were divided into three classes on the basis of risk, with increasing rigor from Class I to Class III; and second, they were divided into seven categories (preamendment, postamendment, substantially equivalent, implant, custom, investigational, and transitional). It is not surprising that a complicated system emerged from these numerous divisions.
In brief, Class I, general controls, is the least regulated class, and it requires producers to comply with regulations on registration, premarketing notice, record keeping, labeling, reporting of adverse experiences, and good manufacturing processes. These controls apply to all three classes of devices. Manufacturers of Class I devices must register their establishments and list their devices with the FDA and notify it at least ninety days before they intend to market a device. Tongue depressors are an example of a Class I device. Class II devices are those for which general controls are considered insufficient to ensure safety and effectiveness and for which information exists to establish performance standards. Well over half of the devices on the market are in Class II.
Class III consists of those devices for which general controls alone are insufficient to ensure safety and efficacy and for which information does not exist to establish a performance standard and the device supports life, prevents health impairment, or presents a potentially unreasonable risk of illness or injury. Only those devices placed in Class III receive premarket reviews similar to those conducted on drugs. The manufacturer must submit a premarket approval application (PMA) that provides sufficient data to assure the FDA that the device is safe and efficacious. Only a small fraction (about 8 percent) of all devices are placed in Class III, including heart valves and other implanted products.
The categories set forth in the law established guidelines for classification. For example, implanted devices are assumed to require a Class III placement, and custom and investigational devices can be exempt from premarket testing and performance standards. Examples of implants include cardiac pacemakers and artificial hips; custom devices include dentures and orthopedic shoes; and at present investigational devices include the artificial heart and positron emission tomography (PET) imaging machines. Transitional devices are those regulated as drugs (such as copper-based IUDs) before the passage of the law, and they are automatically assigned to Class III. Devices on the market at the time the law was passed are referred to as preamendment or preenactment devices . These products are assumed to be in Class I unless their safety and efficacy cannot be ensured without more regulation. Manufacturers can petition for reclassification under certain circumstances.
One provision has assumed a greater significance in practice than was perceived when the law was drafted. New devices that are shown to be "substantially equivalent" to a device on the market before the law was passed are assigned to the same class as their earlier counterparts, and manufacturers have to provide information on testing and approval only if the earlier products required it. To receive the designation of substantial equivalence, section 510k requires producers to notify the FDA at least ninety days before marketing. This premarket notification must contain enough information for the FDA to determine whether the device is substantially equivalent to a device already being
marketed.[24]
The process is referred to as a 510k after the number of the provision in the bill.
A product need not be identical, but it cannot differ markedly in design or materials. If a device meets the equivalence requirement, it can go directly to market without further scrutiny. The benefits to manufacturers of "a 510k" are enormous, as their products can enter the market quickly and without great effort.This complex regulatory framework invites maneuvering on the part of producers. Unlike the drug law that treats all new chemical entities (NCEs) alike, the medical device amendments present a large number of options and opportunities to manipulate the system. The FDA's management of the device law has been very controversial. Frequent hearings and investigations by Congress have tended to conclude that the FDA has not measured up.[25]
For example, Report of the House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, MedicalDevice Regulation: The FDA's Neglected Child (Washington, D.C.: GPO, 1983); Comptroller General Report to Congress, Federal Regulation of Medical Devices—Problems Still to Be Overcome, GAO-HRD-83-53 (Washington, D.C.: General Accounting Office, September 1983); United States General Accounting Office, Report to the Chairman, Senate Committee on Governmental Affairs, Early Warning of Problems Is Hampered by Severe Underreporting, GAO-PEMD-87-1 (Washington, D.C.: General Accounting Office, December 1986); and General Accounting Office, Briefing Report to the Chairman, House Subcommittee on Health and the Environment, Committee on Energy and Commerce, Medical Device Recalls: An Overview and Analysis 1983-1988, GAO-PEMD-89-15r (Washington, D.C.: General Accounting Office, August 1989).
On the other hand, some in industry have accused the FDA of overregulation, inefficiency, and harassment. For its part, the FDA claims that limited resources and expanding demands hamper enforcement.