FDA, FCC agree to collaborate on regulation

By Brian Dolan

FDAThe Federal Communications Commission and the Food & Drug Association signed a memorandum of understanding (MOU) today that each agency would work with the other to create an efficient regulatory structure for wireless-enabled medical devices and services. The agreement has a five-year sunset provision built into it.

"The MOU between the FCC and the FDA is intended to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices," the document reads. "This MOU is designed to enhance knowledge and understanding between the agencies and to increase the efficiency of their respective regulatory processes by providing for the sharing of information and expertise between the agencies for broadband and wireless enabled medical devices, and to increase regulatory predictability and understanding of regulatory requirements for medical device providers."

The FCC and FDA have decided on four key goals for the collaboration. They are:

a. Further enhance information sharing efforts in order to further ensure the safety and efficacy of medical devices.

b. Improve the efficiency of the agencies’ regulatory processes in areas where their jurisdiction overlaps, such as with respect to various medical devices that utilize broadband and wireless technology.

c. Promote efficient utilization of tools and expertise for product analysis, validation, and risk identification.

d. Build infrastructure and processes that meet the common needs for evaluating broadband and wireless enabled medical devices.

For more on the FCC, FDA collaboration, read the full text of the MOU here (PDF)

More regional news

Ralf-Gordon Jahns (pictured on the right) is the Managing Director of Research2Guidance, a leading market analyst and strategy consultancy company for the global digital health market.