Understanding FDA Guidance On Connected Medical Devices

In the coming years, we expect to see an explosion in the number of interoperable
medical devices. These are connected medical devices that have the ability to
connect to different technologies and devices, even from other manufacturers.
The U.S. Food and Drug Administration also recognizes the growing importance of
these connected devices and issued final guidance on Sept. 6, 2017, relating to their
safety.

Interoperable medical devices can provide incredibly valuable data to health care
providers and patients. Health information that may have taken several doctors’
visits to gather could literally be at a patient’s fingertips with a tap on their
smartphone.

At the same time, these devices often have highly sensitive applications, such as
pacemakers and blood pressure monitors, that give rise to unique safety risks. The
guidance urges safety and transparency in developing and designing interoperable
medical devices, and highlights information that manufacturers should include in
premarket submissions and device labeling. This final guidance follows a draft
guidance issued by the FDA in January 2016.

Please see our full article as published on Law360.