FDA (Finally) Returns Industry’s Calls for Mobile Medical Apps Guidance, in Medical Device and Diagnostic IndustrySeptember 24, 2013
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "FDA (Finally) Returns Industry's Calls for Mobile Medical Apps Guidance."
Following is an excerpt:
The release of the final mobile medical apps (MMA) guidance marks an important step forward on a decision that has been put on hold for more than two years. Those of us who have been involved in the FDASIA Workgroup on Health IT and pushing for the release of the landmark guidance are obviously delighted that FDA chose to go forward with publishing the guidance. This action shows both courage and a genuine desire to promote innovation.
Although much of the document is carefully crafted, some of the language remains subject to interpretation and is a bit confusing. These ambiguities will likely be worked out; however, they don't seem to be very fundamental right off the bat. That said, the guidance is important because it aims to provide clarity in the muddled mobile medical app landscape and outlines a distinct framework for the future of this innovative sector.