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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Hemostat devices: Absorbable hemostat device manufacturers Johnson & Johnson/Ethicon and Danish firm Ferrosan have until June 7 to submit updated comments to FDA in opposition to a proposed down-classification of the products, which consist of wound dressing and a chemical or biological agent used to control bleeding during surgical procedures. The agency reopened the comment period after it expired in January in response to requests from the two firms for more time. The companies, which market Surgicel (Ethicon), Instat (Ethicon) and Surgifoam (Ferrosan), have already gone on the record against the reclassification, which would allow new products to enter the market based on 510(k) clearance rather than the more involved PMAs that were required for their products. FDA proposed the reclassification in October 2006 after two advisory panel meetings in 2002 and 2003. Ethicon and Ferrosan argue that FDA has not been transparent enough in its proposed rulemaking and that the suggested policy's product definition is too broad, among other issues...

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