Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of a “device.” On March 1, 2013, six Republican members of the House Committee on Energy and Commerce sent a letter to FDA expressing concern that an overly broad approach to regulating mobile medical apps could hamper innovation, due in part to the application of the medical device excise tax to these apps.
As we’ve discussed previously, FDA released a draft guidance document in July of 2011 proposing to regulate a subset of certain mobile apps that meet the definition of a medical device, termed “mobile medical apps.” FDA’s draft guidance met with significant criticism, due in part to FDA’s proposal to regulate relatively low-risk apps that automate simple calculations. Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012, directed FDA to convene a working group with a diverse set of stakeholders and issue a report to Congress by January of 2014 setting forth a “risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” This advisory group is being staffed by the HHS Office of National Coordinator for Health Information Technology. Last year, Representative Mike Honda introduced the Health Care Innovation and Marketplace Technologies Act of 2012, which would create an Office of Wireless Health Technology within FDA.
Continuing the trend of Congressional interest in mobile apps, the letter poses four questions to FDA:
- When will FDA issue a final or updated guidance?
- Has FDA addressed the effect of the excise tax on smartphones and distributors of applications?
- Will the actual use of a smartphone, tablet, or app be a factor in whether FDA chooses to regulate that item as a device?
- How many apps have sought clearance/approval from FDA, and what is the processing time for these submissions? Has FDA taken action against apps already on the market?
FDA’s answers to these questions could provide an interesting update into the agency’s activities regarding mobile medical apps, as well as its approach to examining “actual use” in determining a device’s “intended use.”