FDA Issues Final Guidance Documents on Medical Device Data Systems and Mobile Medical Applications


On Friday, February 6, 2015 the FDA posted a final guidance document on medical device data systems (MDDS). This confirms the FDA's position that due to the low risk these devices pose to patients and their importance in advancing digital health, it does not intend to enforce compliance with the regulatory controls that otherwise would apply. The finalization of this policy should inspire the development of new technologies to better use and display this data.

In addition, the FDA updated its Mobile Medical Apps guidance to be consistent with the final MDDS guidance.

The FDA is hosting a webinar on February 24, 2015 to discuss the final guidance documents and two draft guidances released in January on low risk products intended for general wellness and medical device accessories.