Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in multiple publications regarding the FDA draft guidance on medical device accessories, released on January 16, 2015.
Following is an excerpt from Bloomberg BNA’s Health Care Daily Report:
Health-care attorney Bradley Merrill Thompson, with Epstein Becker & Green P.C., Washington, told Bloomberg BNA that the draft guidance contains “a few big wins” for technology developers.
He said the device accessory guidance, if made final, would ensure that many device accessories will be classified as lower risk when assessed alone than if assessed as part of a parent device.
Thompson said the draft guidance also aims to reiterate the FDA's stance that smartphones—as long as they aren't marketed specifically as accessories to medical devices—aren't considered medical device accessories, even though they can run mobile medical apps and connect to medical devices.
Thompson said he hopes the FDA in its final guidance clarifies that certain health IT tools that analyze and display medical device data, such as data aggregators, aren't considered medical device accessories.
Related reading:
FDA Week, 01/22/2015
Politico, 01/20/2015
FierceMedicalDevices, 01/20/2015
MobiHealthNews, 01/20/2015
HealthDataManagement, 01/19/2015
FierceHealthIT, 01/16/2015
VentureBeat, 01/16/2015
Bloomberg BNA’s Health Care Daily Report, 01/16/2015
