FDA Outlines 'Anticipated Details' of New Oversight Approach for Laboratory Developed Tests

Laboratory Developed Tests (LDTs) are tests that are intended for clinical use and designed, manufactured and used within a single laboratory. On July 31, 2014, the federal Food and Drug Administration (FDA) provided advance notice to Congress (as required by statute) of its intent to issue draft guidance for the regulatory oversight of LDTs, after its longstanding approach of “enforcement discretion” for these tests.

This article, written by a team of Foley lawyers from the health care, intellectual property, and FDA practices, originally was published in the BNA Medical Devices Law & Industry Report, and discusses the FDA’s new and significantly different approach to the oversight of LDTs. Continue reading the full article.

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