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- Proposed FDA Rule on LDT Oversight Under Review by OMB
On June 14, the US Food and Drug Administration (FDA) filed a notice of proposed rulemaking for the oversight of laboratory-developed tests (LDTs) with the White House Office of Management and Budget (OMB). To regulate LDTs, the FDA is following the formal rulemaking process, which the CAP will analyze, engage, and advocate for minimizing burden on laboratories and ensuring patient access to tests.
The notice of proposed rulemaking filing was expected after legislation concerning the oversight of LDTs stalled in 2022. The FDA said it would move forward with the formal regulatory process in the absence of congressional action. Once the OMB will likely conclude its review by mid- to late August or early September, after which the proposed regulation would be released for public comment. Most public comment periods last 60 days but the CAP anticipates it being extended beyond that time period. As prescribed by the statute, the FDA would then have two years to finalize the regulation for implementation. As the VALID Act was not enacted in 2022, the FDA will not be implementing provisions outlined in the legislation.
The CAP will keep its members updated with the latest information on regulatory action as news develops.