Senators seek further clarification on mobile apps
A bipartisan group of senators seek further clarity and transparency from the FDA regarding its mobile medical apps policy.
On March 18, 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.) sent a letter to the FDA, urging further clarification on the rules for medical software application developers to promote innovation and keep consumers safe in light of changing technologies.
"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 wrote in their letter to FDA Commissioner Margaret Hamburg.The FDA published its final guidance on mobile medical apps last September, outlining a risk-based approach. The agency also expressed its intention to focus on high-risk apps.
“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. They asked her to reply to a list of nine questions within three weeks.
Read the complete letter.
Editor
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.