Posted by Michael Wonder on 16 Sep 2023
FDA’s final breakthrough devices guidance now includes technologies that address health disparities
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program now can be used to benefit populations impacted by health care disparities.
The update, issued 14 September, also adds a new text aimed at deciding whether a device provides a “more effective” treatment than others, and expands its criteria for breakthrough devices to include non-addictive products to treat pain or addiction.
