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Labs, Test Makers Urge Congress To Pass Diagnostic Reforms

 
• By Sue Darcey

More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.

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Test manufacturing and laboratory groups are pushing Congress to move forward with legislative reforms on US FDA and Centers for Medicare and Medicaid Services regulatory oversight of lab developed tests (LDTs) and IVDs this summer, a topic that has been sitting on the back burner of key congressional committees for several years now.

Last year in March, Reps. Larry Bucshon, R-Indiana, and Diana DeGette, D-Colorado, of the House Energy and Commerce Committee came up with a plan for regulating diagnostics, outlined in discussion draft, called the Diagnostics Accuracy and Innovation Act (DAIA), that many, though not all, industry and lab groups agree is at least a good starting framework. (Also see "Diagnostics Reg Overhaul Floated In US House" - Medtech Insight, 21 March, 2017

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