Senators Seek Information on FDA’s Mobile Health App Plans

March 20, 2014 in News

On Wednesday, a bipartisan group of six senators sent a letter to FDA Commissioner Margaret Hamburg asking for clarification on the agency’s regulations for mobile health applications, The Hill’sHealthwatch” reports (Viebeck, “Healthwatch,” The Hill, 3/19).


In September 2013, FDA issued final guidance for mobile health applications. The guidance said FDA will focus oversight on apps that:

  • Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
  • Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 12/12/13).

Meanwhile, FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT are expected to provide Congress with a risk-based regulatory framework for health IT by the end of March.

The report, which was due to Congress by January 2014, is required under the Food and Drug Administration Safety and Innovation Act (iHealthBeat, 2/26).

Letter Details

The letter was signed by Sens.:

  • Lamar Alexander (R-Tenn.);
  • Mark Warner (D-Va.);
  • Michael Bennet (D-Colo.);
  • Orrin Hatch (R-Utah);
  • Richard Burr (R-N.C.); and
  • Tom Harkin (D-Iowa) (Wicklund, mHealth News, 3/19).

In the letter, the senators praised FDA’s work on mobile medical applications. However, they requested more details on the agency’s plans for oversight of mobile medical apps and asked if the agency needed the support of legislation.

They wrote, “[M]ore transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” adding that the FDA should be careful “that innovation is not stifled through uncertainty or over regulation” (Ethridge, CQ Roll Call, 3/19).

The lawmakers asked FDA to provide details on:

  • How congressional legislation creating medical software categories would affect FDA’s oversight of health-related mobile applications;
  • The number of emails FDA has received with questions about the agency’s mobile app regulations, as well as the agency’s average response time;
  • The policies and practices created by FDA to help firms unfamiliar with mobile health app regulations;
  • Whether statutory definitions could help to clarify any confusion about risk levels assigned to medical software;
  • FDA’s process for determining whether medical software updates warrant additional FDA approvals;
  • The process for determining whether applications with new functions should be overseen by FDA;
  • FDA’s level of coordination with ONC and FCC in responding to concerns over interoperability;
  • FDA’s approach for regulating complicated medical software; and
  • Any additional legislative tools that would help FDA provide better oversight.

The lawmakers asked FDA to respond to their questions within the next three weeks (Dolan, MobiHealthNews, 3/19).

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