With New FDA Input, Momentum for LDT Regulation Accelerating
In what has been called a “critical milestone” towards enacting a comprehensive new oversight framework for diagnostic tests, the U.S. Food and Drug Administration (FDA) released its comments on the draft bipartisan bill crafted last year by Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) on the House Energy and Commerce Committee. While the Diagnostic Accuracy and Innovation Act (DAIA) was introduced back in March 2017, momentum seems to be building towards enactment of a new diagnostic oversight framework, possibly by the end of the year. The draft bill, which was created with industry representation on the Diagnostic Test Working Group, established a new category of in vitro clinical tests (IVCTs) that includes both finished products (such as test kits), and lab test protocols (known as laboratory developed tests [LDTs]). In what can be seen as a compromise, the draft legislation included the creation of a new FDA center that would regulate test development and manufacturing, while lab operations would be overseen by the Centers for Medicare and Medicaid Services (CMS), which currently oversees CLIA-certified laboratories. In early August, the FDA submitted 59 pages of comments on the DAIA. Reaction to the FDA’s Technical Assistance (TA) document was strong and […]

Subscribe to Clinical Diagnostics Insider to view
Start a Free Trial for immediate access to this article