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 and sophistication of LDTs since then has been the central argument for the FDA – and Hillebrenner in particular – for why they belong under the agency’s regulatory umbrella