Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests


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This On the Subject was authored by McDermott+Consulting Senior Director John Warren and McDermott lawyers Paul W. Radensky, Eric Zimmerman and Michael W. Ryan.

On July 31, the U.S. Food and Drug Administration (FDA) released a notice to Congress announcing the agency’s intent to release a draft guidance providing a framework for bringing laboratory-developed tests under FDA’s regulatory authority. The notice included a copy of the draft guidance, which is expected to be released for comment on or after September 29. Under the proposed framework, many laboratory tests, which are currently offered by laboratories under regulatory oversight by the federal Clinical Laboratory Improvement Amendments as well as state licensure, would require compliance with FDA’s medical device regulations, including, registration and listing, premarket review, medical device reports, and quality systems regulations. Phase in of these requirements would not begin until after a final guidance is issued and would occur over a nine-plus-year period, with those tests which FDA considers to be highest risk falling under FDA’s review requirements first.

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