Latex-containing device reg's applicability to polymers should be clarified -- Convatec.
This article was originally published in The Gray Sheet
LATEX-CONTAINING DEVICE RULE'S APPLICABILITY TO POLYMERS that certain latex proteins should be clarified by FDA, Bristol-Myers Squibb subsidiary Convatec says in recent comments to the agency. Commenting on a June 24 proposed rule, Convatec asks FDA to state whether restrictions proposed in the reg apply to devices that do not list latex as an ingredient of the product but that nonetheless contain latex protein polymers.
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