Articles on Law, Science, and Engineering

The FDA and Medical Devices[index]

For most of its history, the FDA's predominant interest has been food and drugs. If one studies the evolution of FDA regulations, one sees new regulatory ideas originating in food regulations, then being adapted to drugs, then to devices. Until very recently, devices have been the regulatory backwater of the FDA, receiving relatively little attention. This is not surprising: the 1976 law that directed the FDA to regulate devices was written to allow most devices already on the market to escape review and to allow many devices to enter the market without a premarket approval. The Safe Medical Device Act of 1990 and the Medical Device Amendments of 1992 directed the FDA to inquire more closely into device safety issues. At the same time, a new FDA chief was appointed who had a personal interest in device regulation. The result has been a new regulatory climate for medical devices.

While it will take years for the new statutory changes to be reflected in final FDA regulations, this should not engender complacency in the clinical engineering community. An activist FDA commissioner can have a profound impact on the industry through using the informal powers of the agency. It is important to understand the distinction between the FDA's technical rules, i.e., the statutes passed by Congress and formal regulations promulgated by the agency, and its power. Breast implants provide a good example. There has been no significant change in the laws, regulations, and scientific knowledge concerning breast implants in the last few years. Within a period of a few months, however, breast implants were driven off the market and their manufacturers were faced with the specter of billions of dollars in product liability claims. Most of the damage was done through adverse publicity, which, unlike formal agency actions, cannot be challenged in court. This incident highlights the danger in compliance policies that follow the letter of the law but ignore the politics of regulation.

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