The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take into consideration the unique challenges of conducting medical device clinical trials, according to a top agency official.
Under the 2023 Consolidated Appropriations Act, lawmakers have instructed FDA to require diversity plans for all Phase 3 clinical trials conducted for drugs and biologics, and the same for all devices and diagnostics that use the 510(k), premarket approval (PMA), de novo, and investigational device exemption (IDE) pathways, with some exceptions.
“When the legislation was passed at the end of last year, we started working immediately, figuring out what are we going to need in terms of expertise, what are we going to be reviewing, what’s the process to even accept them,” Michelle Tarver, deputy center director and chief transformation officer at FDA’s Center for Devices and Radiological Health (CDRH), told attendees at the 2023 MedTech conference…
