Bakul Patel, the FDA's policy advisor for the Center for Devices and Radiological Health (CDRH), let slip during a "what if" modeling session with industry members at the Food and Drug Law Institute's annual meeting in Washington, D.C., on April 6, that with a year-end publication date for the FDA's smartphone app guidance, plus a 60- to 90-day comment period to follow, final guidance isn't likely to be available until next Spring, according to medical devices newsletter The Gray Sheet. The estimate comes roughly one month an official's statement in March that the guidance would be issued "sometime" this year.
Industry members and Patel ran through hypothetical cases of smartphone apps and devices that the agency may or may not regulate. In the end, the exercise didn't result in any kind of consensus among participants, the newsletter reports.
Mark Gryzwa, research and development director for Boston Scientific, indicated he saw the potential for any mobile devices that attached to his company's cardiac monitoring units to be regulated. The issue of connectivity between smartphones and medical devices is still in flux, and "it moves so fast," that his company likely will take a conservative view of possible FDA regulation, he said during the session.
Alan Goldberg, a health law professor at Fairfax, Va.-based George Mason University, told the group that he saw many of the hypothetical devices and software acting more as data storage systems, which don't require FDA approval.
Patel himself acknowledged that the mHealth industry simply is not the same as other industries it covers, but did point to clinical functionality as the most likely trigger for FDA response. Companies that make health claims in their marketing, or actually perform clinical operations on their mobile devices, may be the first targets, he indicated.
That dovetails with what FierceMobileHealthcare reported in February about the FDA carving out low-end mobile devices that merely store or transfer medical data, and possibly paving the way for regulation of devices that actually use, change or interpret clinical data.
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