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FCC-FDA Public Meeting on Converged Health Care and Communications Technologies

June 15th, 2010 by Julius Knapp - Chief, Office of Engineering and Technology

By Julius Knapp, Office of Engineering and Technology, and Phoebe Yang, Office of Strategic Planning and Policy Analysis.

The FCC and FDA have announced their first-ever joint meeting to discuss how to get innovative wireless medical devices to consumers as quickly and safely as possible. Recommendation 10.3 of the FCC’s National Broadband Plan recognized the need for close cooperation between the two agencies so that the convergence of medical devices and wireless communications ultimately will bring new options for care to consumers that can save money, time – and lives. Click here for more information on the meeting.

The combination of devices, applications and communications networks is enabling clinicians and patients to give and receive care anywhere at any time. For example, mobile sensors in the form of disposable bandages and ingestible pills relay real-time health data over wireless connections. Diabetics can receive continuous, flexible insulin delivery through real-time glucose monitoring sensors that transmit data to wearable insulin pumps. Medical body area networks monitor various vital signs and detect the onset of a patient “crash” while in a hospital in time for treatment.

With these new solutions come new challenges. When medical and wireless devices and applications converge, the regulatory lines become blurred. Uncertainty regarding regulatory frameworks and approval processes can discourage private sector innovation and investment, and ultimately delay or prevent the availability of such solutions.

The FCC and the FDA heard industry’s and consumers’ concerns and are holding a joint public meeting to address these challenges. We propose to bring together various stakeholders from manufacturers to practitioners to patients to better understand the types of devices and applications that are being introduced, clarify the requirements that apply, and improve the regulatory and approval processes to the extent we can.

We need your input on the key challenges to make this endeavor a success and ask that you respond to our Public Notice. While we have a long history of collaboration with the FDA, we are excited about the prospect of working even more closely with our sister agency to ensure every American has the opportunity to benefit from promising health IT solutions that can positively impact health outcomes, improve quality of life and reduce health care costs.

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