Lab Professionals Oppose Draft Dx Reform Bill; Lab, IVD Industry Ready To Work With Congress
The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.
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The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked Congress to stay closer to Reps. Diana DeGette's and Larry Bucshon’s original Diagnostics Accuracy and Innovation Act draft bill language.
US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.
FDA Commissioner Scott Gottlieb told Reps. Larry Bucshon, R-Ind. and Diana DeGette, D-Colo., that he favors their approach to regulating laboratory developed tests, as spelled out in their draft Diagnostics Accuracy and Innovation Act bill released last spring. The traditional device approval process is a "poor fit" for LDTs, he added.