January 2017
FDA’s ‘Conversation Starter’ Paper Suggests Altered Approach for Laboratories

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating Laboratory Developed Tests (LDTs) in the future than previously understood by laboratories and other stakeholders.

The paper, published on January 13, provides a review of LDT guidance previously proposed by the agency and an analysis of public comments and feedback received from stakeholders. The FDA’s consideration of appropriate LDT oversight has been ongoing for a number of years. In 2014, the agency proposed a new oversight scheme for LDTs, drawing the criticism of many industry participants that the FDA would be over-regulating this type of testing. In November of 2016, the FDA announced that it would not finalize its 2014 proposed guidance, signaling that opposing arguments that LDT oversight should be incorporated within Clinical Laboratory Improvements Act (CLIA) oversight and other mechanisms may have carried weight.

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