Senators Urge FDA Not to Stifle Mobile Medical Apps Through Over-Regulation

On March 18, 2014, a bipartisan group of U.S. Senators, including 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.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, urging the FDA to provide further clarity in its policies regarding medical mobile applications (MMAs).

In their joint letter, the senators stated their position on MMAs, “It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation. 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. … We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike.”

In 2013, the FDA issued final guidance for oversight of MMAs. The final guidance, entitled “Mobile Medical Applications: Guidance for Industry and FDA Staff,” uses a risk-based approach to define what the FDA considers to be a MMA, with the agency’s efforts concentrated on high-risk medical software.  The FDA has also provided the  MMA industry with the following examples: (1) MMAs the FDA regulates; (2) MMAs that are not medical devices; (3) MMAs the FDA has approved; and (4) MMAs for which the FDA will exercise enforcement discretion.

While the Senators appreciate the FDA’s decision to use a risk-based approach to regulation, they are still concerned about possible over-regulation. And they are not the only members of Congress to indicate their concern.

In fact, the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013, H.R. 3303, proposed October 22, 2013 in the House of Representatives by U.S. Rep. Marsha Blackburn (R-Tenn.), seeks to curb the FDA’s regulatory powers by deregulating less risky medical software.

Then on February 10, 2014, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, S. 2007, which seeks to clarify the extent to which the FDA can regulate clinical and health software.

In their letter, the senators also asked Dr. Hamburg to provide responses to the following questions about current policies and oversight of MMAs and other medical software within three weeks:

  • 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?
  • 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?
  • In addition to the dedicated e-mail address, what policies and practices has FDA established to further assist innovator companies that are not familiar with FDA’s regulations and requirements applicable to medical device manufacturers?
  • 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?
  • 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?
  • 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?
  • Are there additional legislative tools that the FDA needs to better oversee the regulation of medical mobile applications?
  • What approach does the FDA use to regulate complex medical software with multiple and separate functions?