USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules

The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that includes a new proposed rule on removing outdated regulations as well as several returning rules that have been highly anticipated or highly controversial with stakeholders.

“The regulatory actions forecasted in this agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration,” the HHS wrote in its preamble. “Accordingly, this agenda contains rulemakings aimed at ensuring that the nation is well-prepared to manage COVID-19 going forward, building and expanding access to affordable, quality health care, addressing health disparities and promoting equity, and boosting the mental health and wellbeing of children and families, among other policy priorities.”…