A group of senators are now urging the Food and Drug Administration to provide clarification on how the agency would classify mobile applications.
The latest action follows the FDA's release late last year of final guidance on how it would regulate mobile medical apps, a move that drew strong support from mHealth advocates but left some critics wondering if too much regulation would prevent the fast-paced industry from moving forward with much-needed innovations.
While the senators praised the FDA for using a risk-based approach in classifying apps, they said the agency must be sure it doesn't go overboard with regulation.
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"It is important for the FDA to be well-equipped with the proper tools to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation," the letter stated. "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 have also asked the FDA to answer the following questions:
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 e-mail 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?"
The group of senators consists of Michael Bennet, D-Colo.; Orrin Hatch, R-Utah; Tom Harkin, D-Iowa; Lamar Alexander, R-Tenn.; Mark Warner, D-Va.; and Richard Burr, R-N.C.
This isn't the first time Congress has sought to clarify how mHealth would be regulated.
Last month, Sens. Angus King, I-Maine, and Deb Fischer, R-Neb., unveiled the Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, which seeks to clarify the extent to which the FDA can regulate health IT.
That followed the Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013, proposed last October in the House by U.S. Rep. Marsha Blackburn, R-Tenn., which seeks to curb the FDA's regulatory powers by deregulating what legislators feel is less risky health IT.
Both of those bills drew a strong response from Bradley Merrill Thompson, a Washington, D.C.-based attorney who advises the mHealth Regulatory Coalition. Thompson said Congress' efforts could leave too much of the mHealth field unregulated, dragging down the industry with ineffective technology and putting patients at risk of injury or death.
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