The U.S. Food and Drug Administration (FDA) recently submitted its anticipated laboratory developed test (LDT) proposed rule to the federal Office of Management and Budget (OMB) for approval. The proposed rule outlines the FDA’s vision for providing oversight over laboratory developed tests, which are tests designed, manufactured, and used within a single laboratory.
The FDA indicated last year that if Congress did not clarify the Agency’s authority to regulate LDTs, it would use the regulatory process to secure oversight authority over LDTs. Congress, however, was unable to approve the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have provided FDA with clear authority over LDTs, largely due to fierce opposition from ASCP and other pathology and laboratory associations, laboratories, and other stakeholders.
ASCP does not oppose a role for FDA federal oversight of some LDTs; however, the Society was concerned the VALID Act imposed significant and unnecessary burdens and costs on these critical patient tests, which could have undermined patient access to critical testing services.
When the proposed rule is published, ASCP will work to ensure that it does not unreasonably interfere with diagnostic innovation by clinical laboratories and that it ensures patient access to quality laboratory services.
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