FDA guidance

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps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.
New FDA guidances aim to increase clarity on when developers need to resubmit 510(k)s
By Jonah Comstock | 04:37 pm | October 24, 2017
Industry, patient groups respond to FDA draft guidance on patient data access
By Jonah Comstock | 04:36 pm | August 24, 2016
FDA clarifies the line between wellness and regulated medical devices
By Brian Dolan | 06:39 am | January 16, 2015