Tweaked FDA bill removes hurdle to medical app guidance
The Food and Drug Administration can proceed with its creation of guidance for mobile medical apps after all.
House and Senate negotiators yesterday tweaked a controversial section of the FDA Safety and Innovation Act (S.3187) that initially required the FDA not only to lay out its entire proposed strategy but also to convene a working group of external stakeholders to provide input on that strategy prior to issuing those guidelines, mHIMSS.org's Eric Wicklund reported. The modification calls for only the U.S. Department of Health & Human Services to draft such a report--with input from the FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission.
Without the change, the guidance likely would have been delayed until at least 2013.
"Last night, the mobile health industry avoided a big stumbling block with the help of Congress," Brad Thompson, an FDA expert with Washington, D.C.-based law firm Epstein Becker Green who serves as general counsel for the mHealth Regulatory Coalition, said in an email to MRC members obtained by FierceMobileHealthcare.
"[T]hose who acknowledge that FDA has a legitimate role to play wanted to avoid any delay in the desire to get needed clarity around the scope of FDA regulation so that [the] industry and investors could move forward."
Thompson's letter added that with the decision "many in [the] industry breathed a sigh of relief."
The bill, according to Health Data Management's Joseph Goedert, also aims to combat drug shortages by allowing delivery systems to repackage and send such medications to affiliate hospitals. The bill also created unique medical device identifier deadlines.
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