THERE IS A ROLE FOR the U.S. Food and Drug Administration in regulating medical devices.
The rapid development and widespread use of technology is a prominent feature of medical care, and Americans generally expect their physicians to have access to the latest, most sophisticated medical technology.But only a small fraction of the medical devices and surgical techniques in clinical practice have been subject to formal evaluation, and many technologies are being used under conditions where they may not be appropriate.
Clearly, a balanced regulatory process is needed - one that assures the safety and effectiveness of medical devices and simultaneously facilitates their development and clinical use.
In 1976, Congress passed the Medical Device Amendments. These amendments created a hierarchical system for evaluating medical devices and authorized the FDA to categorize devices into one of three classes based on the level of regulation required.
When the 1976 Medical Device Amendments extended the authority of the FDA to regulate medical devices, they allowed the regulation to be tailored carefully to the specific nature of each device.
This regulatory approach reduced the number of unsafe and ineffective devices coming into the marketplace, raised the standards of the industry without unduly discouraging technology innovation and protected public health.
Based on the experience gained since the passage of the 1976 amendments, Congress passed the Safe Medical Devices Act of 1990 and the Medical Devices Amendments of 1992.
These laws give both the FDA and the manufacturers more flexibility. They permit the FDA to lower the classification of many devices - including some life-supporting and life-sustaining devices - if the manufacturers can provide reasonable assurance of their safety and effectiveness.
Despite the FDA's carefully nuanced approach to regulation, various industry critics of the regulation process have contended that the FDA is stifling innovation; and, on the opposite side, some consumer activists have contended that the FDA is not doing enough to protect public health.
As medical devices have become more complex, the FDA rightly has required some manufacturing information and performance testing, even though the agency itself has often been short of both staff and expertise.
The FDA has attempted to achieve a reasonable balance between the flexibility needed to bring new medical devices into clinical practice and the degrees of control necessary to assure the safety and effectiveness of those devices.
In general, professional medicine (specifically, the American Medical Association) does not view the regulatory process as a serious impediment to the infusion of new technologies into patient care.
Finally, the FDA is paying more attention to the advertising and promotion of devices in response to claims made by some manufacturers.
This attention serves to ensure that the labeling and promotion of devices are truthful and accurate and that health-care providers and patients alike have the information they need to select and use these devices properly.