The Food and Drug Administration plans to issue final guidance about how it will regulate medical mobile applications before Oct. 1, an agency official told a House Energy and Commerce subcommittee Thursday.
Christy Foreman, director of the office of device evaluation in the FDA's Center for Devices and Radiological Health, said the FDA is finalizing the guidance and expects to release it before the end of the government's fiscal year.
The FDA issued the draft guidance in mid-2011. Delays in the release of the final guidance have prompted criticism from lawmakers and mobile app developers and investors, several of whom provided testimony earlier this week to House Energy and Commerce subcommittees expressing concern about regulatory uncertainty and its impact on the market.
Some medical mobile apps have received FDA clearance in recent years, although the vast majority of the estimated 40,000 health and wellness apps on the market do not require federal oversight.