The Food and Drug Administration (FDA) released the final regulation on the oversight of laboratory-developed tests (LDTs) with some changes advocated for by the CAP. The CAP had opposed the regulation as written and called for several improvements that would ensure patient access to testing and allow for the continued innovation of new tests.

The CAP sent out a special edition of Advocacy Update on April 29 examining the rule and we will provide additional updates on the regulation as new information becomes available. CAP President Donald Karcher, MD, FCAP also issued a statement after the final rule’s release.

In the CAP’s initial analysis, we recognized that the FDA adopted the CAP’s recommendation to allow LDTs offered prior to the rulemaking’s issuance to remain under the FDA’s enforcement discretion policy. The CAP will work to clarify with the FDA exactly when and which LDTs will continue under enforcement discretion through this provision.

The FDA also acted on the CAP’s recommendations regarding LDTs for unmet needs. The final rulemaking states the FDA will continue to apply enforcement discretion for LDTs developed and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system when an equivalent FDA-authorized test is not available. Previously, the CAP advocated to allow for continued enforcement discretion for clinical laboratories developing and running LDTs meeting the following criteria: offering LDTs in small volumes; serving their local communities with active involvement in patient care; using well-characterized standard tests; and the intended use is for diagnosing rare diseases or meeting other local population needs.

The CAP is continuing to analyze this section of the rulemaking to determine the impact on laboratories.

The FDA is hosting an implementation webinar on Tuesday, May 14.

During the webinar, the FDA will:

• Provide an overview of the final rule amending the FDA's regulations

• Describe the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs).

If you have questions about this final rule that you wish to submit for possible discussion during the webinar, email CDRHWebinars@fda.hhs.gov. All questions must be received by May 7, 2024, to be considered for the discussion.

You can register here.

The CAP will continue to be engaged on this important issue and work closely with the FDA, Congress, and other stakeholders to ensure that oversight of LDTs will not prevent patient access to safe and effective LDTs and will not unduly impact our members or their laboratories.

For questions about the FDA regulation or CAP Advocacy, please contact our DC Office at advocacyupdate@cap.org.