Concern in the CDRH has led to the formation of an EMC Working Group. This group was charged by the Deputy Center Director, Dr. Elizabeth Jacobson, to:
- assess all device areas to identify EMC concerns;
- coordinate the development of a strategy to assure EMC in all appropriate devices
- provide a focal point for actions;
- keep the Center Director and his staff informed of activities involving EMI/EMC.
This initiative involves virtually all of the CDRH offices and functions. The formation and subsequent accomplishments of the Group have already had an impact on the regulatory approach, research, and interactions with the device industry.
The EMC Working Group has developed a draft strategy to address EMC concerns across all appropriate device areas. This involves awareness (and education), regulation, research, cooperation with other agencies and organizations, and coordination and cooperation with manufacturers and users.
CDRH has long recognized that the majority of devices likely do not have major problems with EMI. Nonetheless, there are some critical device areas where the threat from EMI could directly impact upon the life and well-being of the patient. Rather than implement additional burdensome requirements over a broad spectrum of devices, CDRH is focusing on those areas where EMI has an established presence, is problematic, or could affect the critical function of the device.