Washington, D.C. – Colorado U.S. Senator Michael Bennet today applauded the arrival of a new Food and Drug Administration (FDA) action plan to regulate medical software. The initiative is based off of policies passed in The 21st Century Cures package, including the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, which Bennet coauthored with Senator Orrin Hatch (R-UT).
The MEDTECH Act encourages medical innovation by clarifying the FDA’s regulatory oversight of health software products.
“This new initiative will boost the use of emerging medical technologies,” Bennet said. “It’s an action plan that recognizes that our regulatory approaches must be updated to keep up with innovative digital tools. Coloradans and all Americans will benefit from the production of safe and effective digital devices that can help people manage their health. “
“We need to make sure our approach to innovative products is efficient and that it fosters, not impedes, innovation,” FDA Commissioner Scott Gottlieb said. “Recognizing this, and understanding that the potential of digital health is nothing short of revolutionary, we must work toward establishing an appropriate approach that’s closely tailored to this new category of products.”
Bennet first introduced the MEDTECH Act in 2014. It was passed as part of the 21st Century Cures Act in 2016.
The FDA published the guidelines in its Digital Health Innovation Action Plan, which outlines the implementation of the MEDTECH provisions.