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- FDA Moves Forward with 60-Day Comment Period for LDT Regulation
The US Food and Drug Administration (FDA) will proceed with a 60-day comment period for its proposed regulation on laboratory-developed tests (LDTs), the agency announced on October 30. The CAP and other organizations had requested a 120-day comment period due to the complexity and magnitude of the proposal on laboratories and patient access to LDTs.
In response to the CAP, the FDA said: “After considering the requests and other factors, including the extensive background of public comment on this topic and the public health benefits of proceeding expeditiously, FDA has determined to proceed with the standard 60-day comment period.”
The CAP remains engaged with the FDA’s proposed regulation and is preparing our comments on the proposed rule, which are due on December 4. The CAP will report more information to CAP members on this issue as news develops.