A group of U.S. Senators have sent a letter to Food and Drug Administration (FDA) Commissioner, Margaret A. Hamburg, M.D. seeking further clarity and transparency on how the agency plans on regulating medical mobile health (mHealth) apps.
Senators Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn), Mark Warner (D-Va), and Richard Burr (R-NC) sent the letter to Dr. Hamburg, asking for further clarification for medical software application developers. Referring to the FDA's final guidance over mHealth apps, the Senators note that the agency used a risk-based approach in defining what it considers to be a mobile medical application, focused on high-risk medical software in particular. The Senators say a large number of apps could be actively regulated under this definition and more transparency is required for developers.
"While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated," the Senators wrote in the letter.
The Senators include a series of questions within the letter that it requests the FDA answer within three weeks of its receipt. Some of those questions include:
- Compared to current FDA guidance, what impact would Congress establishing categories of medical software in legislation have on the FDA’s oversight of medical mobile applications?
What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?
How is the FDA determining what types of medical software updates, even minor updates, change the function of or add a function to the medical software and would require FDA review?
How has the FDA been coordinating with the Office of the National Coordinator and Federal Communications Commission to address the recent FDA Safety and Innovation Act working group’s concerns over interoperability?
The letter, in its entirety, can be read by clicking the link below.