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Lawmakers call on FDA to issue stricter bone graft guidance
A bipartisan group of Michigan lawmakers sent the FDA a letter yesterday calling for stronger guidance in testing bone tissue products and screening donors. The statement comes as the CDC works to control a U.S. tuberculosis outbreak that spread via infected bone material used by dentists and orthopedic surgeons. There have been two deaths and at least 36 exposures. It’s the second tuberculosis outbreak linked to the biomaterial device company, Aziyo Biologics.
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