Coalition group urges FDA to publish mobile apps final guidance
The mHealth Regulatory Coalition (MRC) is exerting more pressure on the FDA, calling for the agency to publish its final guidance on mobile medical apps as soon as possible.
“There has been some discussion recently regarding whether FDA should delay the release of the final guidance until after the secretary of the Department of Health and Human Services (HHS) develops its comprehensive regulatory strategy for all health IT as required by the FDA Safety and Innovation Act (FDASIA),” according to a June 19 notice. “We disagree with that view.”
In March, several mobile industry representatives and legislators urged the agency to finalize its July 2011 draft guidance during a series of U.S. House of Representatives Energy & Commerce hearings. At the time, Christy Foreman, director of device evaluation in FDA’s Center for Devices and Radiological Health, indicated that the release of the agency's final guidance would take place by Sept. 30, the end of the fiscal year.
However, talk of postponement prompted MRC to call for its publication, stressing that the required HHS comprehensive strategy for all health IT would only make broad recommendations while the “FDA guidance is focused on providing specific details of whether different mobile medical apps will be regulated or not—this is the level of regulatory detail app developers need now.”
In its call to hasten publication, MRC outlined five reasons to proceed expeditiously:
- It would enable more predictable investment in mHealth technologies
- It would benefit industry through deregulation
- It would help ensure patient safety
- It would ensure no overlap with the health IT regulatory strategy required by FDASIA
- It would answer the board consensus on the need for the guidance
“The MRC opposes any delay in the issuance of the final guidance and believes the immediate release of final guidance will benefit industry, enable more predictable investment in innovative mHealth technologies and help ensure patient safety,” the coalition wrote.