Diagnostics Reg Overhaul Floated In US House
Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.
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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.
There are changes afoot in the regulation and reimbursement policy for IVDs in the EU and US. When it comes to personalized medicine, and companion diagnostics in particular, are the two markets becoming more polarized? Medtech Insight asked US- and EU-based attorneys at Hogan Lovells.
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.