A bipartisan group of senators on March 18 sent a letter to the Food and Drug Administration urging the regulatory agency to provide further clarity and transparency in its policy regarding mobile medical applications. 

In the letter to FDA Commissioner Margaret Hamburg, the senators stated: “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.”

In September, the FDA published its final guidance on mobile medical apps that outlined a risk-based approach and stated its intention to focus on high-risk apps. However, 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-N.C.) have urged the FDA to further clarify rules for medical software application developers to promote innovation and keep consumers safe in light of changing technologies. 

“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, who gave Hamburg three weeks to reply to a list of nine questions regarding the regulation of mobile medical apps.

Text of the letter is available here.

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access