The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center for Radiological Health (CDRH) publishes the list of planned topics each year, divided into higher priority “A-list” final and draft guidance topics, as well as a “B-list” of guidance documents to be published as agency resources allow. Finally, CDRH publishes a “Retrospective review” list of guidance documents issued in previous years that may benefit from revision.
The planned guidance topics from the FDA’s CDRH provide a level of transparency so that US medical device market applicants and registrants may know what areas to focus on to achieve compliance…
