bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance
Stefan Willemsen, a top executive at diagnostics firm bioMérieux, has been working through AdvaMedDx with FDA, and with US House members to signal industry support for a bill to create a separate diagnostic regulatory framework at FDA. He spoke about that effort and explained how his firm’s products can be helpful in pinpointing cases of antibiotic resistance.
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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.
Guidance To Put More Combo Products Into Device Realm Due Out In Fall, FDA Commish Gottlieb Tells Congress
A combination products guidance “to move more products into the device realm” will be released either at the end of this summer or in early fall, US FDA Commissioner Scott Gottlieb told lawmakers at a hearing. He also explained how new 21st Century Cures authority to hire biomedical scientists with very specific expertise will help the agency.
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.