On November 19th, the House Energy and Commerce Subcommittee on Health held a hearing to examine the federal regulation of mobile medical applications (mobile apps) and other health software.   Earlier, on September 25, the FDA released guidance on this issue, describing how it intends to regulate mobile medical apps pursuant to its authority under the Federal Food, Drug and Cosmetic Act to regulate “medical devices.”  Lawmakers, however, are concerned with the expanse of the FDA’s authority and scope of the FDA’s interpretation of what constitutes a “medical device.”  Accordingly, some legislators are pursuing new legislation to solidify a standard for medical software and restrict the FDA’s authority.  The recent Subcommittee hearing focused on whether mobile health software should be regulated as a medical device and whether Congress or the FDA should set the rules.

The FDA’s View

While concern has arisen that … Read More »