Six US senators sent the FDA a letter this week to check in on the agency's interactions with mobile health app developers since it published its final guidelines for mobile medical app regulation last year. The senators who signed the letter -- Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr -- stated that they wanted to ensure the agency's oversight over medical apps remained current with changing technologies and that they believed the FDA should provide even more clarity on how the "range of medical software might be appropriately regulated". That said, this group of senators lauded the agency's risk-based approach to regulating medical apps as outlined in the final guidance.
The senators went on to ask the FDA to respond to nine questions included in the letter within three weeks time. Of particular interest was a query about how many emails the FDA has received with questions about its mobile medical apps guidance and how speedily on average the agency was in addressing such emails.
The full list of questions posed to the FDA were as follows:
1. 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?
2. We understand you have set up an e-mail address to answer questions about FDA’s regulation of specific mobile medical applications. How many e-mails have you received to date and what is FDA’s average response time in calendar days?
3. In addition to the dedicated email address, what policies and practices has DFA established to further assist innovator companies that are not familiar with FDA’s regulations and requirements applicable to medical device manufacturers?
4. What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?
5. 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?
6. When a medical mobile application presents a novel function that has never been classified by the FDA, what procedures are used to determine if and how that application should be regulated by the FDA?
7. 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?
8. Are there additional legislative tools that the FDA needs to better oversee the regulation of medical mobile applications?
9. What approach does the FDA use to regulate complex medical software with multiple and separate functions?
It just so happens that in about three weeks time the FDA and HHS are also likely to present Congress with its report on feedback from the FDASIA working group's suggestions for how it should regulate health IT moving forward. Meanwhile, others in the Senate have offered up a bill called the PROTECT Act, which aims to exempt some types of medical software from the FDA's purview.