The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the center’s focus in the current fiscal year is on transitioning COVID-19 devices and diagnostics from emergency use authorizations (EUAs) to traditional marketing authorizations and addressing issues around digital health.
On 17 October, CDRH published its annual priority A and B lists of guidances that it wants to develop in FY2023, as well as a list of past guidances it wants to review and possibly update. The items on the A list are guidances that FDA will prioritize to complete before the end of FY2023, while the ones on the B list are guidances it will try to complete in the same time frame, depending on available resources…
