Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules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fall 2023 unified agenda for the US Food and Drug Administration (FDA) that includes a new proposed rule on removing outdated regulations as well as several returning rules that have been highly anticipated or highly controversial with stakeholders.“The regulatory actions forecasted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.”
The document contains 72 total rules, with 43 proposed rules, 28 final rules, and 1 rule in a pre-rule stage. New to the unified agenda is a proposed rule to revoke certain regulations between that concern mutual recognition of pharmaceutical good manufacturing practices, medical quality system audio reports, and medical device product evaluation reports between the US and the European Community.
“FDA is proposing this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice,” according to the rule.
The rest of the unified agenda consists of rules that have been brought over from the spring 2023 unified agenda, including a highly-anticipated final rule on Quality Management System Regulation (QMSR), which would adopt portions of the ISO 13485 standard. FDA officials said at a recent 2023 enforcement conference that the proposed rule has been submitted to the Office of Management and Budget and the agency is hoping it will be finalized soon (RELATED: FDA compliance chiefs detail FY2023 trends, plans for FY2024, Regulatory Focus 07 December 2023).
Another major carryover from previous agendas is a proposed rule on regulating laboratory developed tests (LDTs) as medical devices that would phase out FDA’s regulatory discretion for the tests. The proposed rule received over 3,000 comments from stakeholders with many asking that the agency extend the comment period and questioning whether FDA has the legal authority to regulate LDTs (RELATED: FDA won’t extend LDT rule comment period, Regulatory Focus 31 October 2023).
Other notable rules were carried over from the spring unified agenda, including as a pre-rule on the recalls of products subject to the jurisdiction of the FDA, a proposed rule on creating a new kind of patient labeling for human prescription drug products and blood products, a proposed rule on removing certain preventive controls for human food, a proposed rule updating biologics regulations surrounding Biologic License Applications (BLAs), a proposed rule on procedures to suspend a clinical hold on a medical device, a proposed rule on a final rule on allowing waivers of informed consents for minimal risk clinical investigations, and a final rule allowing legacy biologic products to reference drug master files in a BLA.
Fall 2023 Unified Agenda
