Six senators have written FDA Commissioner Margaret Hamburg, MD, asking for clarification about the Food and Drug Administration's role in the regulation of health IT products.
In the letter, Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.), ask nine questions about current regulation activities, including how the FDA decides which new devices and software updates warrant regulation, and how new laws and input from the ONC has or will affect regulation.
The senators' ultimate goal is more transparency in the FDA's regulatory process for health IT products. "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," wrote the senators.
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