FDA Draft Guidance Could Spur Innovation in Diabetes, Cardio Spaces
Friday, October 3, 2014
FDA’s proposed hands-off approach to regulating low-risk storage and communication devices paves the way for further innovation in health IT, particularly for devices intended for diabetes management and cardiovascular disease risk assessment.
A recent FDA draft guidance titled Medical Device Data Systems, Medical Image Storage Devices, Medical Image Storage Devices, and Medical Image Communication Devices proposes that the agency refrain from regulating certain low-risk storage and communication systems. Following the tri-agency FDASHIA Health IT Report issued in April 2014, which proposes a risk-based framework for health information technology, FDA’s proposed hands-off approach for these systems has signaled a general commitment to implementation of such a framework. In addition to the agency’s involvement in the FDASIA report, FDA’s change of course is driven by a number of other factors, including greater agency experience with these types of technologies, their low-risk nature, public feedback received as part of the FDASIA health IT risk-based framework, and the foundational role that these devices play in the larger health IT ecosystem.