The U.S. Food and Drug Administration announced Oct. 30 that it will not extend the standard 60-day comment period for its proposed rule on laboratory-developed tests (LDTs).
“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, the FDA has determined to proceed with the standard 60-day comment period,” the agency states in its announcement.
The proposed rule would phase out the current FDA enforcement discretion approach for LDT oversight, and once fully implemented in 2028, the rule would reclassify all in vitro diagnostics offered as LDTs to the same enforcement approach as other in vitro diagnostics.
The College of American Pathologists (CAP) was among those trade organizations requesting an extension of the commenting period to 120 days, given the proposal’s “complexity and implications for laboratory testing.” The CAP, which is in the process of drafting comments on the proposal, met with the FDA on Nov. 13 to ask clarifying questions about the proposed regulation.
All electronic or written comments must be submitted to the FDA by Dec. 4.
Sources:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
https://www.cap.org/advocacy/latest-news-and-practice-data/november-14-2023
