A bipartisan group of senators requested on Wednesday that the FDA provide clarification and transparency on its medical mobile applications policy to avoid confusion among stakeholders.
Sens. Orrin Hatch (R-Utah), Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa), Mark Warner (D-Va.) and Michael Bennet (D-Colo.) requested clarification in a letter to FDA Commissioner Margaret Hamburg.
“It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation,” the senators said.
The FDA issued a final guidance last year regarding its oversight of medical mobile apps.
FDA oversight focuses on mobile apps that present a risk to patients if they do not work properly and those that impact the functionality or performance of traditional medical devices. The FDA applies the same risk-based approach to assure the safety and effectiveness of those apps as it does with other medical devices, the agency said.
The senators said more transparency is needed to avoid stakeholder confusion about how a wider range of medical software could be appropriately regulated.
“We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike,” the senators said.