Infection Reduction Labeling Act
This bill amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to authorize solid antimicrobial copper alloys, and products made from such alloys, to be marketed, distributed, or sold with labels about their infection reduction and control efficacy if the antimicrobial claims made on the label are consistent with the results of federally-funded clinical trials finding: (1) greater than 25% reductions in infection rate or 50% reductions in microbial burden, or (2) statistically significant reductions in infection rate or microbial burden.
Requirements to submit or review efficacy data related to the antimicrobial claims are waived for these alloys if the claims are consistent with the results of the trials.
An alternative process to modify the labeling of an alloy may be used in lieu of the current process.
This bill amends the Federal Food, Drug, and Cosmetic Act to exclude a product that is made from the alloy and has the antimicrobial labeling from regulation and treatment as a drug or device.
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