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Senators Request Clarity on mHealth App Regulation from FDA
Healthcare Informatics: Senators Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn), Mark Warner (D-Va), and Richard Burr (R-NC) sent the letter to Dr. Hamburg, asking for further clarification for medical software application developers. Referring to the FDA's final guidance over mHealth apps, the Senators note that the agency used a risk-based approach in defining what it considers to be a mobile medical application, focused on high-risk medical software in particular.
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