Medical Device

Radiological Health, Part 3
by Food and Drug Administration (FDA)

(Page 3 of 4)

President Gerald R. Ford, in signing the law, said, "The Medical Device Amendments of 1976 eliminate the deficiencies that accorded FDA 'horse and buggy' authority to deal with 'laser age' problems." He added, "I welcome this legislation and commend the FDA, who identified the need, cooperated in its development, and finally, will be entrusted with its enforcement."

The 1976 amendments defined devices similarly to drugs, but noted that drugs cause a chemical reaction in the body, whereas devices do not. They called for all devices to be divided into classes, with varying amounts of control required in each one.

Tongue depressors, for example, would fall under general controls of the types already existing (Class I); wheelchairs would be subjected to performance standards when general controls were deemed insufficient to assure product safety and effectiveness (Class II); while artificial hearts would be required to go through pre-market approval (Class III). The agency's first device performance standard was developed for impact-resistant lenses in eyeglasses and sunglasses.

The final provisions of the 1976 amendments closely resemble the Cooper Committee recommendations. In addition to the medical device inventory and classification requirements, Class III device manufacturers were required to notify the FDA prior to marketing. New devices that were substantially equivalent to pre-1976 devices could be marketed immediately, subject to any existing or future requirements for that type of device.

Good Manufacturing Practice (GMP) regulations also were authorized at that time. These are a set of procedures to ensure that devices are manufactured to be safe and effective through quality design, manufacture, labeling, testing, storage, and distribution.

"The development of the GMP regulation included significant interaction with the medical device industry, which resulted in a set of requirements that stood the test of time for 20 years," recalls David M. Link, former director of the FDA's then Bureau of Medical Devices, at a 20th anniversary of the medical device law. Link, who served as bureau director between 1974 and 1980, said it is a gratifying reflection that "a number of the processes initiated in the late 70s are still in place."

During the 1980s, spectacular growth began to occur in the related field of medical diagnostic devices, which aid in the detection of diseases and other conditions, such as pregnancy.

"It was an exciting time to be in FDA and the bureau," says Victor Zafra, former acting director of the Bureau of Medical Devices from 1980 to 1982, "because many of the initial policies and regulations were developed at that time." Zafra remembers approval of the first monoclonal antibody in vitro diagnostic test kit, as well as extended-wear soft contact lenses.

With the development of electronic technology came a host of new products and, with them, potential harmful radiation exposure. But the tools to solve their potential dangers, as recognized by the act - training, research, and state collaboration - were perceived as less enforcement-oriented than the traditional FDA approach to regulation. Responsibility for radiation product activities fell under the agency's then Bureau of Radiological Health, which was combined in 1982 with the Bureau of Medical Devices and renamed the CDRH.

"Consequently, there was the challenge of preserving these 'softer' radiation programs and at the same time building a credible compliance program in the new center," says John C. Villforth, who served as director of the CDRH from 1982 to 1990. The most important challenge facing the new organization, he emphasized, was the merging of the two bureaus into a single center.

"Both bureaus had a similar culture in that they were involved with 'things' as opposed to foods or drugs," he said, "and so there was a reasonable fit in the disciplines - primarily physical sciences and engineering - that were needed to regulate the combined programs."

But Mark Barnett, the CDRH's assistant director for education and communications since its inception in 1982, says it isn't just the emphasis on physics and engineering that distinguishes medical devices and radiological equipment from drugs.

"The safety of most medical devices depends to a large degree on their being used properly," he says. "That's true in the case of a surgeon implanting a prosthetic device in a patient's body, an anesthesiologist operating a complex gas delivery machine, or a diabetic patient using a blood glucose monitor at home. And so, with devices," he adds, "an important part of our job is to educate health care practitioners and patients about safe use."

Villforth adds, "I believe the melding of the talents of both bureaus into the combined center was responsible for the success that CDRH has maintained over the years."

The Medical Device Amendments also gave the FDA authority to deal with the notification, repair, replacement, and refund of defective devices, and the agency was authorized to ban any device that presents a substantial deception or substantial unreasonable risk of injury or illness. Thus, the final law greatly strengthened the FDA's authority to regulate medical devices, but retained the fundamental concept of the Cooper Committee report that regulation should be carefully tailored to the type of device involved.

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.