Medical Device

Radiological Health, Part 2
by Food and Drug Administration (FDA)

(Page 2 of 4)

The Need for Medical Device Regulation

What was clearly needed, according to many, was national regulation of the medical device industry. Besides being subjected to enforcement actions against products that had already tragically demonstrated their danger to people, medical devices were officially defined as drugs. Calling a medical device a drug, claimed a U.S. senator from Missouri at the time, was like "calling a sheep's tail a leg." Legislation was eventually introduced to modernize the 1906 act. The contentious Senate debate that led up to enactment of the Federal Food, Drug, and Cosmetic Act of 1938 had much to do with the definition of a medical device being added to the law.

Nevertheless, from 1938 until the early 1960s, devices were subject only to policing by the FDA. The agency determined whether a device was safe and effective. If not, the agency could bring charges in the courts only against products or materials that were found to be defective, unsafe, filthy, or produced in unsanitary conditions (adulterated), or against statements, designs, or labeling that was false or misleading (misbranded). There was, however, no requirement for pre-market testing, review, or approval.

The FDA's enforcement resources would be strained to the limit over the next 25 years as the agency attempted to deal with such widely distributed quack machines and gadgets such as Ruth B. Drown's Radio Therapeutic Instrument.

Proponents of this device claimed it could cure ailments ranging from a simple fungus growth to a potentially fatal kidney malfunction. Worse yet, when patients' illnesses became too debilitating for them to make the trip to the doctor's office for treatment, they were told they could be treated by remote control.

"That's what's wonderful about the Drown machine," FDA court transcripts quote one doctor as saying. "It's just as effective when the patient is miles away, as when he or she's here." Court documents revealed that four years after one woman faithfully used the radio instrument, she died of the very cancer that Ruth B. Drown's machine, in truth, was incapable of diagnosing or curing.

Such devices were successfully removed from the market. These actions, however, consumed such a large amount of the agency's resources that consideration was given to enactment of additional legislation to further strengthen the FDA's authority.

In 1962, President John F. Kennedy proposed changes to the way medical devices entered the market. Extensive congressional hearings were held on proposals to revise the FD&C Act in a number of different ways, including a requirement that medical devices be regulated comparably to, but separately from, new drugs. There were signs that progress was being made on the proposals.

A few months later, however, news came that thousands of European babies whose mothers took the sedative thalidomide had been born with terrible deformities. The issue of medical devices was then set aside so that health officials could focus on the tragedy.

Congress considered a comparable device law when it passed the 1962 drug amendments. The companion bill, however, to require pre-market approval of new medical devices under the same type of system applied to new drugs was deleted from that final legislation.

The Medical Device Amendments of 1976

During the 1960s and into the 1970s, the FDA's attention turned to the wide range of life-saving medical devices. The agency devoted considerably more effort to ensuring the safety and effectiveness of these new devices, while still trying to protect the public against the fraudulent ones.

The Cooper Committee - chaired by Theodore Cooper, M.D., then director of the National Heart and Lung Institute - was organized in 1970 specifically to study medical devices as part of President Richard M. Nixon's endorsement of medical device legislation. The committee recommended that any new legislation be specifically targeted to the device industry, because devices presented entirely different issues from drugs. It also suggested that different classifications for medical devices be created, which would tailor the regulatory controls to the risks involved.

Because Congress could not initially agree on the draft legislation for medical devices, the FDA forced the issue and, on its own initiative, took the committee's recommendations by taking inventory of all medical devices being used and then classifying them according to their potential risks.

"That finally got the attention of the House as well as the Senate," said Peter Barton Hutt, who served as chief counsel for the FDA between 1971 and 1974, "and they both began to show renewed interest in late 1974."

The 1976 Medical Device Amendments Become Law

While the Cooper Committee recommendations were being debated in Congress during 1972 and 1973, pacemaker failures were reported. And in 1975, hearings took place on problems that had been reported with the Dalkon Shield intrauterine device, which caused thousands of reported injuries. Those two incidents helped underscore the need for the Medical Device Amendments, enacted in 1976.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.