FDA Issues Draft Guidance on LDTs

Friday, December 12, 2014

Source: Genetic Engineering and Biotechnology News

The FDA today issued draft guidance detailing its plans for regulating laboratory-developed tests (LDTs) that it deems as “high-risk” along the lines of Class III medical devices—setting up a showdown with academic medical centers and other developers of the tests, which have opposed efforts at imposing new rules.

In a few days, the agency said, it will launch a 120-day public comment period that will begin with publication of a formal notice of the release of the draft guidances in the Federal Register. Released by the FDA today were two draft guidance documents: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs); and FDA Notification and Medical Device Reporting for Laboratory Developed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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