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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Absorbable hemostats, the saga continues: FDA is again reopening the comment period on its proposed reclassification of absorbable hemostatic devices from high-risk class III to medium-risk class II status, the agency said Sept. 11. FDA first proposed the downclassification in October 2006 after hearing recommendations from an advisory panel in 2003, but criticism from current absorbable hemostat makers Ethicon and Ferrosan has delayed the process (1"The Gray Sheet" June 16, 2008, p. 3). The companies urged FDA to delay the final rule until an updated administrative record was made public. FDA complied, and has posted more than 30 additional items on the dockets since July 7. Comments on the proposed rule and accompanying draft special controls guidance are due Oct. 14
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