FDA to issue 2 draft guidance documents on lab-developed tests

Washington, DC-The U.S. Food and Drug Administration (FDA) recently notified Congress that it intends to issue drafts of guidance documents on lab-developed tests.

The draft guidance is titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”

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The move comes after several senators called for the White House Office of Management and Budget to release the draft guidance for public comment. Earlier this year, the Centers for Disease Control and Prevention (CDC) released a notice that a common lab-developed test for Lyme disease commonly results in false-positives.

“The draft Framework Guidance proposes a risk-based, phased-in framework for oversight of LDTs in a manner that is consistent with FDA’s current regulation of in vitro diagnostic devices,” says Sally Howard, deputy commissioner for policy, planning, and legislation for the FDA, in a letter to the Senate Committee on Health, Education, Labor, and Pensions.

“The accompanying draft guidance describes the manner in which laboratories may provide notification and comply with medical device adverse event reporting,” Howard wrote.