FDA, FCC Team Up to Regulate Wireless Devices

The U.S. Food and Drug Administration (FDA) and Federal Communications Commission (FCC) have formed a partnership to regulate wireless medical technology, a field that could help the health care industry reduce skyrocketing costs and improve patient care.

In a rare joint appearance late last month in Washington, D.C., FDA Commissioner Margaret Hamburg and FCC Chairman Julius Genachowski cemented the agencies’ partnership by signing a memorandum of understanding and releasing a joint statement of principles. According to the joint statement, the FDA and FCC should “provide leadership and encourage innovation and investment in new health care technologies that enable patients, doctors and other health professionals to access the highest quality of care.” It also states that the two agencies should establish clear regulatory pathways, processes and standards to bring broadband and wireless-enabled medical devices to market.

“The benefits that wireless technologies can provide to healthcare are clear, but to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness,” Hamburg said at the start of a two-day medical technology conference in the nation’s capital. “Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap.”

The FDA and FCC established four key goals for their collaboration, according to the memorandum of understanding signed by Hamburg and Genachowski. Those goals include:

•Enhancing information sharing efforts to further ensure the safety and efficacy of medical devices;
•Improving the efficiency of the agencies’ regulatory processes in areas where the jurisdiction overlaps, (for example, medical devices that utilize broadband and wireless technology);
•Promoting efficient utilization of tools and expertise for product analysis, validation, and risk identification; and
•Building infrastructure and processes that meet the common needs for evaluating broadband and wireless-enabled medical devices.

The partnership helps the FCC achieve its goal of streamlining processes to promote wireless medical technology. That goal was outlined in the agency’s National Broadband Plan, which found that wireless communications devices and networks in the health care industry is helping to rapidly transform medicine by enabling doctors to treat patients anywhere at any time while improving quality and controlling costs. The plan, released in March, recommended that the FCC and FDA clarify regulatory requirements and the approval process for converged communications and health care devices so consumers and health care providers can enjoy the benefits.

“Not only will cutting-edge devices improve medical care and reduce health costs, they will catalyze private investment to create jobs and spur economic growth,” Genachowski said. “All Americans stand to benefit from broadband-enabled wireless health solutions. We must unleash innovation while assuring patient safety, and we must partner effectively to do so. This joint initiative reflects a shared commitment on behalf of the FCC and FDA. This action will promote investment and innovation in technologies, help realize potential cost savings, and deliver real health benefits to the American people.”

The FCC’s partnership with the FDA was announced less than two weeks after the agency created a $400 million fund for broadband infrastructure projects at medical facilities.