Labs, Test Makers Urge Congress To Pass Diagnostic Reforms
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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In a Dec. 6 blog post, US FDA officials continued pressing for a new system of diagnostics regulation that puts laboratory-developed test services (LDTs) on the same footing as IVD test kits, all under a new framework where only about 10% of tests would require pre-market review.
The balance of power will be shifting in Washington, DC, following the Nov. 6 US midterm elections, but that probably will not mean major changes for medtech policies. Here are some key takeaways from the election for device and diagnostics companies.
The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.