MASSDEVICE ON CALL — A group of Senators is looking for more information on the FDA’s plans for mobile medical applications, querying federal official in attempts to "clarify any uncertainty with respect to assigning risk level of medical software."
The coalition posed 9 questions about the FDA’s plans for mHealth, including concerns about how to handle software updates, novel indications that the FDA doesn’t have prior experience with, how to approach multi-faceted software and how the agency expects to make itself available to app-makers who need help navigating the regulatory process.
The letter was signed by Senators Orrin Hatch (R-Utah), Michael Bennet (D-Colo.), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.), MobiHealthNews reported.
Healthcare regulators, lawmakers and app-makers have gone back and forth on mobile app regulation, with the FDA ultimately choosing a mostly hands-off approach to new software. The Senators lauded the FDA for its risk-based approach to regulation and decision to allow app-makers, for the most part, to determine for themselves when they should undergo FDA review, but asked that the agency provide more information.
"While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated," they wrote in a formal letter to FDA Commissioner Margaret Hamburg.
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