Originally published May 1996
James G. Dickinson
Perhaps more than anything else, the regulatory history of the 1976 Medical Device Amendments has been characterized by mutual suspicion.
Most of this suspicion has unquestionably come from FDA, partly because, while industry has many other concerns besides FDA, the agency's Center for De-vices and Radiological Health (CDRH) has the comparative luxury of having almost nothing to think about except industry. If one company is caught marketing intraocular lenses, artificial heart valves, or catheters that pose avoidable risks to patients, CDRH has the human-enough tendency to suspect that this may not be the end of the problem--that it may, in fact, be the proverbial tip of the iceberg. Ask any experienced policeman about human nature, and you'll likely get a bleak diagnosis. So it is with FDA, appointed by Congress in 1976 to be the device industry's policeman.
On industry's part, there is great ignorance of FDA's true character and purpose. None but the largest of companies have the resources to acquire and sustain intimate familiarity with FDA and its rationales and processes. Suspicion and even fear are natural consequences of this ignorance. Regulatory consultants and lawyers, called upon to help companies overcome difficulties with the agency, are like- ly to amplify this suspicion and fear, possibly to gain continuing employment.
MEDICAL DEVICE AMENDMENTS: NEEDED REGULATION
Like most major health legislation in our country's history, the Medical Device Amendments responded to serious problems and public pressure. The device industry at that time was ineffectively regulated, partly under the Radiation Control Act, partly under the Public Health Act, partly under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and partly under no law at all.
No disaster brought the first medical device law into being in the way that the elixir of sulfanilamide tragedy and the thalidomide birth defects had helped propel the two major drug law changes. But the Dalkon shield controversy inconveniently erupted as the framers of the Medical Device Amendments to the FD&C Act were nearing the final stages of their work. The amendments became the world's first regulatory scheme tailored specifically for medical devices, based partly on precedent and also incorporating some novel, well-meaning, but not well-informed concepts.
CLASS II PERFORMANCE STANDARDS
The most notoriously ill-advised of these new concepts was mandatory performance standards for moderate-risk or Class II devices. Invented in the academic environment of the National Institutes of Health, this was an attempt to turn an essentially freewheeling private-sector process--standards development--into a regulatory requirement. Those who drafted this requirement believed that FDA would develop or co-opt whatever standards were necessary to permit marketing of the products assigned to Class II. But as the years went by, it became increasingly obvious that the resource-starved agency would never get around to this, because it had more pressing priorities.
If FDA has been consistent about anything, it has for at least 20 years been consistent about its tendency to react to acute embarrassment; but the agency's failure to draft the promised performance standards never became acutely embarrassing. It never seemed to occur to the agency's device managers that nothing breeds contempt for a law more than conspicuous inability to enforce it. Right from the start, the managers' attitude was that medical devices represented different and less critical public health issues than drugs or biologics, and that they should be regulated in a less stringent, more relaxed, more common-sense way.
THE 510(k) LOOPHOLE
Almost as ill-advised was the amendments' 510(k) artifice. Well-meaning but inexperienced legislative draftsmen had no concept of how contentious the "substantially equivalent" yardstick would become in the virgin territory of new-device regulation. As the Bureau of Medical Devices' first compliance director, pharmacist- attorney Larry Pilot, remembers it today, "the proper meaning of substantial equivalence seemed self-evident at the time and needed no definition."
But with the benefit of hindsight, FDA's chief counsel during the final stages of the amendments' prelegislative incubation, Peter Barton Hutt, recently confessed in the context of the current debate over FDA reform that he had "no idea" what the term meant at the time, and still doesn't. Others with various political and legal motives have characterized the 510(k) provisions as a loophole wide enough to drive a whole army through.
Essentially, the definition of substantially equivalent was left to various FDA officials to interpret as prevailing circumstances and applications seemed to require--a dangerous amount of latitude to give regulators, but fully in harmony with the relaxed regulatory climate for devices. After all, devices don't flow through your veins and tissues and don't have the potential to cook your brains or shut your heart down, as drugs do. With only a relatively few exceptions, they're safer.
Gradually, congressional overseers became concerned about the easy-going regulation of medical devices. Inappropriate sales incentives for unnecessary intraocular lens implants, defects in artificial heart valves and pacemaker leadwires, and other postapproval marketplace problems brought critical examinations of the way FDA was regulating devices. And once congressional investigators get the scent of something awry in one area, they're apt to go looking in others. So, with all the newfound wisdom of Monday-morning quarterbacks, the investigators found devices that they felt should have been subjected to the rigorous scrutiny of premarket approval (PMA) review, but had instead slipped into the marketplace on the rubber standard of 510(k).
Even if the substantially equivalent measure had been carefully defined, 510(k) had another problem: the law stipulated that FDA must decide within 90 days whether to block marketing of the substantially equivalent device. There were a couple of close calls, including one that got out into the marketplace on the 91st day when FDA's objection blocking it didn't get out until the 96th.
THE SAFE MEDICAL DEVICES ACT OF 1990
With the Safe Medical Devices Act of 1990 (SMDA), Congress sought to solve such legal ambiguities by empowering FDA to issue an affirmative order permitting marketing under section 510(k). But because manufacturers had become so comfortable with the ease of automatic marketing after 90 days and with the elasticity of the substantially equivalent determination, to many in industry this remedy proved to be a cure far worse than the disease. And, of course, FDA developed such bureaucratic backlogs in issuing the 90-day orders that complete overhaul of the device law became an urgent priority for many companies.
Far more new devices get into the marketplace through the 510(k) route than through premarket approval, but industry saw FDA's implementation of SMDA as a covert program to limit section 510(k)'s practical usefulness to marketers by making it more like the PMA requirement.
Commissioner David Kessler was the convenient scapegoat for industry frustration with the new law. Shocked when the silicone breast implant controversy revealed scientific inadequacies at CDRH, he swore to "take science up a notch" at the center--a sentiment that was fully backed by congressional leadership. Subsequent changes at CDRH, which industry quickly identified as the "drug-izing" of devices, caused much of the present clamor for taking CDRH out of FDA and setting it up elsewhere in the government where, presumably, industry would be able to deal with it more easily.
But this recent rift between regulators and regulatees may have been preordained by the underlying nature of the device industry and the naivete of those who wrote the law to regulate it--compounded by Congress's perpetual reluctance to give FDA even remotely adequate funding and also by FDA managers' earlier readiness to apply lesser regulatory standards to devices than to drugs. The medical device industry is both more diverse and more dominated by small businesses than any other health industry regulated by FDA, a point that was not properly appreciated by the drafters of the 1976 amendments. The very nature of this volatile mix of diversity and smallness is to resist centralized regulation. If a company can define its product as outside the scope of a regulation, it will. In the first five years of the new law, many companies that FDA considered to be makers or distributors of medical devices simply refused to register or said they didn't know they had to.
MANDATORY DEVICE REPORTING: LACK OF COMPLIANCE
Similar attempts to rein in FDA's pervasive reach continue to this day. It's an economic self-preservation instinct common to all businesses to resist government intrusions.
FDA-compiled statistics repeatedly show that device companies are less compliant with regulations than drug companies are. A recent study of those statistics indicated that the incidence of device recalls (4% of products marketed) is approximately 2.5 times greater than that of drug recalls (1.5%), and that device recalls are 50% more likely than drug recalls to involve hazards defined by FDA as "serious." Nevertheless, the agency assigns 42% fewer human resources to device inspections than to drug inspections.
In some ways, this condition can be thought of as growing pains. Large segments of the diverse medical device industry (which is much larger in terms of manufacturing sites than the drug industry is) still have not fully digested the hefty dose of federal regulation they were dispensed in 1976, something that cannot be said about the drug industry.
The device industry's difficulties with regulation can be seen most vividly in the area of medical device reporting (MDR). About 80% of all biennial and for-cause-inspected device companies (i.e., those not being inspected for product approval) are found by FDA to have deficiencies in their complaint files and in carrying out their MDR responsibilities.
There's one very obvious reason for this. Prompt reporting of complaints under MDR would likely invite product liability litigation, so it's not a step that companies take without careful thought. If the company does think carefully (e.g., Is the complaint justified? Does it represent user error, not a device flaw? Is it even our device? etc.), the company is guilty of not reporting in a timely manner, and may be found by FDA inspectors to be in violation of the regulation. This hesitancy to report has been tracked by FDA throughout the last 20 years. Before there was an MDR regulation, the hesitancy was tracked in required notifications of product recalls--often FDA would be advised of these more than a year after the event.
In short, significant portions of the device industry have balked at regulation. Small-business dominated, much of the industry simply cannot afford to maintain a full-time regulatory affairs department or even spare management time to make full use of CDRH's unique Division of Small Manufacturers Assistance, which was set up by the 1976 amendments to help companies that lacked full- or part- time regulatory affairs staffs (although it doesn't refuse to serve those that have staffs). Understandably, small companies feel indignant that coping with FDA should consume so much of their operating budgets.
SCALING BACK FOR THE FUTURE?
Hence, the current concern over FDA reform. Device companies see a chance for regulatory relief. Industry has recently begun extolling the remedial virtues of a largely untested European system of device regulation, which would actually amount to wholesale deregulation. On the other hand, FDA has a fairly consistent history since 1976 of receiving congressional, media, and public pressure to do more of what it has been doing, and to do it quicker and more efficiently.
There seems to be little question that some degree of deregulation is justified. Given all their other mistakes, the framers of the 1976 amendments could not have been completely right about the depth of product regulation they established--as FDA under the Clinton administration's "Reinventing Government" initiative has already recognized. But the real question is, how far do we go? All the way with the system devised by and for the nations of Europe? Or is that system also riddled with potential flaws as yet unrecognized in its home countries--as a recent General Accounting Office study has suggested?
Perhaps from our own mistakes we can draw adequate lessons to guide industry toward better regulation during its next two decades.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry and the author of MD&DI's regular "Washington Wrap-Up" column. *