A bipartisan group of senators is seeking greater clarity and transparency from the Food and Drug Administration (FDA) regarding its policy overseeing certain mobile medical applications, or apps.

On September 23, 2013, the FDA issued its final guidance, saying it intended to not use its regulatory oversight for a majority of mobile medical apps, as they pose minimal risk to consumers. The agency did say it intended to use its oversight for medical apps that present a risk to patients if the apps do not work as intended.

鈥淲hile the FDA鈥檚 final guidance has provided clarity on the agency鈥檚 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,鈥� Sen Michael Bennet (D, Colo), Sen Orrin Hatch (R, Utah), Sen Tom Harkin (D, Iowa), Sen Lamar Alexander (R, Tenn), Sen Mark Warner (D, Va), and Sen Richard Burr (R, NC), wrote, in part, in a March 18 letter to the FDA. 鈥淲e urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike.鈥�