Endotoxin Testing: FDA Update Prompts Time for Review

The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of Health and Human Services updated the agency’s thinking regarding pyrogen and bacterial endotoxin testing requirements—and has (rightly so) prompted medical device manufacturers to take a new look at their endotoxin testing programs.