Sponsors Should Consider Representative Race, Age In Trial Design, US FDA Emphasizes
A final guidance document from the agency outlines how device sponsors should approach racial, ethnic and age diversity in trial enrollment and data analysis.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight new guidance documents were posted to the tracker.
FDA instructs device manufacturers and agency staff on its expectations for designing and analyzing trials to reflect outcomes for patient subpopulations, and also provides recruitment tips in a June 20 draft guidance.
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.