Preemption -- The FDA employs scientific experts charged with reviewing very complex medical device applications. The proposed elimination of medical device preemption would undermine the FDA by allowing lay juries in 50 states to weigh an individual plaintiff's claim, to second-guess the agency's expert scientific analysis regarding a device's safety and effectiveness. Subjecting device manufacturers to conflicting state-law obligations would generate widespread regulatory confusion and discourage investment and research into potentially life-saving devices while providing no real safety benefits for the public.
Since 1993, CHI has worked with policymakers in Washington and Sacramento to identify and advocate for policies to advance biomedical research, promote innovation and job creation, and improve public health. As the 111th Congress convenes, we look forward to working with policymakers to tackle the issues above, as well as other important policies such as permanently extending the R&D tax credit, ensuring comparative effectiveness research is appropriately applied, addressing disparities in our healthcare delivery system, improving science and math education, and modernizing the Medicare system to recognize advances in healthcare made possible by diagnostics and remote monitoring technologies.

CHI represents more than 250 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI's mission is to advance responsible public policies that foster medical innovation and promote scientific discovery.

CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

CHI's Web site is www.chi.org.

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