By Roz Sweeney, Ph.D., Nerac Analyst,
Originally Published: September 19th, 2014
Will Laboratory-developed tests (LDTs) require FDA marketing approval?
Laboratory-developed tests (LDTs) are in vitro diagnostic tests typically used within a single-institution’s CLIA lab. The FDA exempted clinical laboratories from registration and listing of tests almost 40 years ago; however, this exemption may no longer apply if the FDA’s new guidance document is implemented. In this guidance document, Framework for Regulatory Oversight of LDTs (July 31, 2014), the FDA proposes regulating LDTs in a similar manner to how it currently regulates IVD manufacturers.