Medical Device

More Medical Device Milestones
by Food and Drug Administration (FDA)

(Page 4 of 4)

The Safe Medical Devices Act (SMDA) was passed in 1990, and represents the first reform of medical device law since the 1976 amendments. This law modified the amendments to give the public greater protection against dangerous medical devices.

Specifically, the SMDA requires nursing homes, hospitals, and other health care facilities that use medical devices to report to the FDA incidents suggesting that a medical device probably caused or contributed to a patient's death, serious illness, or serious injury. Manufacturers are now required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients who depend on such devices. The SMDA authorizes the FDA to order device product recalls and other actions.

"Looking back to the time that I was center director, mid '91 through '92," recalls James S. Benson, a former CDRH director, "I see a center that was severely challenged. We faced implementation of SMDA under tremendous congressional pressure. We faced a very difficult process, exacerbated by enormous press interest, of trying to figure out how to deal with breast implants."

"At the time, we were trying to find resources that would allow the device law to be fully implemented," Benson says.

In 1992, Congress passed the Mammography Quality Standards Act (MQSA). The act requires all mammography facilities in the United States to be accredited and certified as meeting quality standards as of Oct. 1, 1994. The goal of the MQSA is to enhance the detection of breast disease through high-quality mammography services. After initial certification, facilities must pass annual inspections by federal or state inspectors.

New programs like this "had come the center's way," says D. Bruce Burlington, M.D., the CDRH director from 1993 to 1999. "Organizing and executing to successfully reinvent key center processes, write numerous rules and guidelines at a record rate, and keep the usual work moving on time," he says, "was only possible with the teamwork and high performance that have always made CDRH a great place to work." By October 2002, the FDA reported it had certified 9,306 mammography facilities and conducted more than 96,000 annual and biannual inspections.

The Medical Device User Fee and Stabilization Act (MDUFSA) of 2005 is the latest major medical device law to be enacted. The MDUFSA amends the user-fee system created by the original Medical Device User Fee and Modernization Act of 2002, which allows the FDA to charge a fee for medical device product reviews. The agency uses these funds to hire staff and develop better systems to support effective and timely product reviews, to enact needed regulatory reforms, and to ensure that reprocessed devices are as safe and effective as the original devices. The aim of the legislation is to bring safe and effective devices to the public sooner.

"Timely decisions based on sound science" continues to be the center's goal in bringing new products to the market, says David W. Feigal, M.D., M.P.H., who served as CDRH director from 1999 to 2004. He cited some of the center's accomplishments as the development of approaches with the CDRH team to deal with emerging problems such as reuse of single-use devices, regulation of "home brew" genetic tests, revitalization of the radiological health programs, and the process of recruiting the next generation of CDRH leadership.

30 Years of Medical Device Regulation and Beyond

Two major milestones in the FDA's regulation of medical devices occurred when devices were first brought under federal regulatory control in 1938, and when they were first subjected to pre-market review in 1976. On both occasions, the agency sought to balance the need to protect the public from adulteration and misbranding of medical devices against the need to foster the development of innovative new life-saving medical devices.

Today, among other activities, the CDRH devotes a great deal of time to working cooperatively with other agency centers to resolve issues dealing with combination products, such as drugs that are also considered devices; miniature devices (nanotechnology) that will provide less-invasive surgery, which ultimately will result in quicker recovery times for patients; and FDA training on new technology as it develops.

Because of the agency's timely, science-based decisions, millions of Americans get the medical products they need and can be assured of their safety and effectiveness. The FDA's scientific investment brings tangible public health benefits, such as the development of state-of-the-art diagnostic techniques based on genetic mapping. This, says CDRH Director Daniel G. Schultz, M.D., makes it possible for faster and much more accurate identification of people who are at high risk for diseases such as cancer, or who are prone to experience certain adverse drug reactions.

"When I think about the future of our medical device program," Schultz says, "two words come to mind: 'excitement' and 'challenge.' The excitement comes from the tremendous progress the scientific community is making in unraveling the body's secrets at a genetic and molecular level, and from the promise that these discoveries will translate into life-saving and life-enhancing products."

The challenge, he adds, "will be to regulate these new products so as to assure their safety and effectiveness while at the same time assuring that we don't impede medical progress."

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.