FDA postpones final guidance on laboratory developed tests

The U.S. Food and Drug Administration will not finalize guidance related to laboratory developed tests, instead waiting to work with the next administration and Congress, according to multiple news reports. AHA has repeatedly urged the agency not to regulate LDTs as medical devices, as proposed, saying the draft guidance and regulatory framework would reduce patient access to many critical tests and hinder technological and clinical innovation. It said a better approach would be to modernize and enhance the Clinical Laboratory Improvement Amendments. Similarly, the House Appropriations Committee earlier this year approved report language to accompany its Agriculture Appropriations bill that would direct FDA to suspend efforts to finalize its draft LDT guidance and work with Congress to pass legislation that "addresses a new pathway for regulation of LDTs in a transparent manner." LDTs are not commercially distributed but are developed, validated and performed in-house by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs.