[20201203]IN11548_卫生和公众服务部关于FDA实验室开发试验（LDT）上市前审查的公告.pdf

CRS INSIGHT Prepared for Members and Committees of Congress INSIGHTINSIGHTi i HHS Announcement on FDA Premarket Review of Laboratory-Developed Tests (LDTs) December 3, 2020 Regulation of laboratory-developed tests (LDTs)a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single laboratoryby the Food and Drug Administration (FDA) has been the subject of ongoing discussion, driven in part by an increase in the number and complexity of LDT genetic tests for common conditions. FDA has traditionally exercised enforcement discretion over LDTs, meaning that most of these tests have neither undergone premarket review nor received FDA clearance or approval for marketing. To date, FDA has focused its oversight on IVD test kits or components, which are commercially marketed as opposed to developed and carried out in a single laboratory. In recent years, despite the absence of broader agency guidance on the regulation of LDTs, FDA has asserted authority over certain LDTs that it considers to be higher risk. HHS Announcement On August 19, 2020, the Department of Health and Human Services (HHS) announced that, effective immediately, it was rescinding all