The US Food and Drug Administration’s device center has published its A and B lists of guidance documents it plans to prioritize in fiscal year 2023. Posted annually, the lists are broken down into two tiers, with the A-list containing the guidances the agency intends to give top priority to in FY2023 and the B-list reserved for those the agency will get to if resources and time allow.
According to the lists, published on 17 October, the agency’s Center for Devices and Radiological Health (CDRH) plans to focus on final draft documents outlining transition plans for medical devices that fall within the enforcement policies issued during the COVID-19 public health emergency – as well as devices issued emergency use authorizations (EUAs) during the pandemic