By Emily Ethridge, CQ Roll Call
March 18, 2014 -- A bipartisan group of six senators is asking the Food and Drug Administration (FDA) for more transparency in its oversight of mobile medical applications, and whether legislation is needed to assist the agency.
The FDA has said it will focus its oversight activities on medical software applications that could pose a risk to consumers if there is faulty or imprecise functioning, and not on consumer-oriented functions such as calorie counters. Some lawmakers, however, have called for legislation further clarifying the agency’s regulatory framework.
The senators, five of whom serve on the Senate Health, Education, Labor and Pensions Committee, did not propose their own legislation, but asked whether the FDA needs more legislative tools to oversee mobile medical applications. They also asked what effect legislation establishing categories of medical software would have on the agency’s oversight of applications.
“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 six senators wrote in a letter to FDA Commissioner Margaret Hamburg.
In the letter, the lawmakers asked for more clarity on the rules for software application developers, and requested that the FDA continue working with Congress to ensure proper oversight.
“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,” they wrote. Senate HELP Committee Chairman Tom Harkin, D-Iowa, ranking Republican Lamar Alexander of Tennessee, Utah Republican Orrin G. Hatch, Colorado Democrat Michael Bennet, North Carolina Republican Richard M. Burr, and Virginia Democrat Mark Warner signed the letter dated Tuesday.
In the House, Rep. Marsha Blackburn, R-Tenn., has introduced a bill (HR 3303) that she says would detail the FDA’s oversight responsibilities and ensure that “low risk” applications are not subject to the agency’s regulation. Sen. Deb Fischer, R-Neb., has introduced similar legislation (S 2007) with Maine Independent Angus King.
Last year, Jeffrey E. Shuren, director of the FDA’s Center for Devices and Radiological Health, said such legislation might inadvertently stifle innovation in the medical mobile application marketplace.
He said the FDA’s final guidance, issued last year, allows for flexibility and focuses attention on the high-risk products. The agency said it will look to monitor applications in cases where mobile devices are being designed to deliver services that have long been regulated, such as heart rhythm monitors.
The senators applauded that approach, but said more transparency in the FDA’s oversight plans is necessary.
They asked about the FDA’s approach to regulating complex software with multiple and separate functions, and what procedures the agency uses when an application presents a novel function the agency has not yet classified.
They also asked how the FDA determines which types of software updates change an application’s function or add a function, and require agency review. They asked about what policies the agency has established to help companies, including questions about its special email address devoted to answering questions about specific applications.
In addition, the senators asked about how the FDA has coordinated with the Office of National Coordinator and Federal Communications Commission to address the concerns over interoperability.
The senators requested a response within three weeks of the letter’s receipt.
Kerry Young contributed to this report.
Emily Ethridge can be reached at [email protected].