mHealth Regulatory Coalition Urges FDA To Release Final Apps Guidance

The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible."

The FDA, an agency within HHS, released draft MMA guidance in July 2011 and has publicly stated that they will issue their final guidance by the end of fiscal year 2013. However, according to the MRC, that guidance cannot be finalized fast enough.

"Industry has been awaiting FDA's final guidance on mobile medical apps for nearly two years," states a June 19 MRC position paper that was included with the letter to Sebelius. "There has been some discussion recently regarding whether FDA should delay the release of the final guidance until after the Secretary [of HHS] develops its comprehensive regulatory strategy for all health IT as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of July 9, 2012. We disagree with that view."