Zdrowie i gospodarka · 03/10/2014

FDA Releases Draft Guidance on Laboratory Developed Tests (LDTs) Notification and Medical Device Reporting

The Food and Drug Administration (FDA) has made available a draft guidance document outlining the process for clinical laboratories to report laboratory developed tests (LDTs) to the FDA and the Medical Device Reporting (MDR) requirements for these tests, which are in vitro diagnostic devices used in clinical settings.