FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, […]
Source: Dark Daily - Category: Laboratory Medicine Authors: Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology and Why You Should Prepare Now” clinical laboratory Dark Daily FDA Food & Drug Administration in vitro Source Type: news