IVDs, LDTs, FDA and CLIA. Understanding the alphabet soup of laboratory assays

Laboratory assays (in vitro diagnostics, IVDs) performed on biological specimens are integral to research and clinical care. Both the FDA and CMS (CLIA) regulate laboratory assays, with distinct requirements and responsibilities. Research teams must be aware when FDA or CLIA regulations apply to the use and reporting of results from in vitro testing of biospecimens.Objectives for this session:Understand the difference between the CLIA and FDA regulationsUnderstand when an assay is an investigational device and subject to FDA regulationsUnderstand when CLIA appliesLearn about the process of obtaining CLIA certificationAir date: 3/7/2024 3:00:00 PM
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video