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Hillebrenner Fields Questions On FDA’s Proposed Rule To Regulate LDTs, Says No To Extended Comment Period

 
• By Brian Bossetta

During a recent webinar, Elizabeth Hillebrenner of the US FDA’s device center sought to clarify specifics on the agency’s proposed rule to regulate laboratory-developed tests, which establishes FDA oversight of the tests over a five-year period.

OVERSIGHT
• Source: Shutterstock

In a Food and Drug Administration webinar on 31 October, Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the Center for Devices and Radiological Health (CDRH), fleshed out the FDA’s proposed rule on laboratory-developed tests (LDTs), which phases out general discretion of the assays over five years placing them under the same regulatory purview as other in vitro diagnostics (IVDs).

LDTs have come a long way since the FDA first adopted its general discretion approach to their enforcement as part of the medical device amendments of 1976. The growing complexity...

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