Hyman Phelps and McNamara
Firm Publications

LDTs: The Saga Continues
April 2017

Twenty-five years ago, the Food and Drug Administration (FDA) first announced that it believed it had the authority to regulate laboratory developed tests (LDTs). Since then, the topic has generated intense controversy and resulted in the issuance of several draft guidance documents, intense lobbying, draft legislation, multiple citizen petitions, and threatened litigation. All of this has happened against a backdrop of immense change in the laboratory industry.

Regulating LDTs has been an FDA priority for years. Yet, in the wake of the November 2016 elections, FDA said it would suspend efforts to issue an LDT policy. Presumably, for at least the next four years, FDA will not seek to implement a policy governing the regulation of LDTs.

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