FDA guidances

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps
By Dave Muoio | 03:50 pm | September 26, 2019
The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.
Why the FDA needs to correct bad information on its website
By Bradley Merrill Thompson | 12:07 pm | March 08, 2019
Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.
2017 was an eventful year for digital health regulation at the FDA
By Dave Muoio | 04:42 pm | December 21, 2017
What the FDA did in digital health in 2016
By Jonah Comstock | 02:42 pm | December 30, 2016