In a letter to FDA commissioner Margaret Hamburg, a bipartisan group of senators asks what impact congressional legislation might have on FDA regulation of mobile medical apps and medical software. The March 18 letter urges FDA to be more clear and transparent in its guidance on mobile medical apps. The group, which consists of senators Michael Bennet (D-CO), Tom Harkin (D-IA), Richard Burr (R-NC), Orrin Hatch (R-UT), Lamar Alexander (R-TN), and Mark Warner (D-VA) applaud FDA for taking a risk-based approach in defining how it will regulate medical mobile apps because doing so will allow a large number of applications to be actively regulated. However, they stress that “more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.”
The letter urges FDA to work more closely with Congress and serves up nine questions on the current medical app regulation policy. Of particular note are the questions asking what impact might be had if Congress itself were to create legislation establishing categories of medical software as well as the effect statutory definitions might have on uncertainty with regards to assigning a risk level to medical software. This suggests perhaps there is interest in Congress in classifying software in the same manner that it classifies drugs and pharmaceuticals. The senators are also concerned with providing addition legislative tools to FDA, if needed, to improve medical apps and software regulation.
Other concerns raised by the bipartisan group include:
How quickly and efficiently is FDA responding to email requires about the medical software guidance.
What measures is FDA taking to assist “innovator companies” that may not be readily familiar with medical device regulation and requirements?
How is FDA considering software updates in its regulatory policy?
How will FDA regulate apps that present a novel function that has never been classified before?
How as FDA been working with FCC and the Office of the Nation Coordinator on interoperability?
What approach does FDA take to regulate medical software with multiple and separate functions?
The authors of the letter were unavailable to comment at press time. A FDA spokesperson also declined to comment, saying the agency plans to respond to the Senate letter directly.
The senators have asked FDA to respond to the query within three weeks.
to read the full letter as a PDF.