DSM Biomedical; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of phthalocyanine green to color surgical sutures made of ultra- high molecular weight polyethylene (UHMWPE) for use in general surgery, at a concentration of no more than 0.5 percent by weight of the suture.
Abstract as published in the Federal Register.
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