Tag Archives: Government regulation

January 2024—The Food and Drug Administration’s proposed rule on laboratory-developed tests would phase out its existing enforcement discretion approach for oversight of LDTs. Instead, the FDA would classify in vitro diagnostics offered as LDTs as class I, II, or III medical devices depending on their risk to patients.

July 2023—As the COVID-19 federal public health emergency drew to a close in mid-May, industry experts explained what will and won’t change for the laboratory and weighed the fallout from the drop-off in SARS-CoV-2 testing.