Endotoxin Testing: Make Sure FDAs New Guidance Doesn't Delay Your Product Launch

Presentation Abstract:

For years, endotoxin testing was not a consistent requirement across sterile medical devices.  When it came to review of 510(K) submissions or an ongoing monitoring program a sterile device may or may not have been required to be tested for endotoxin.  With the release of Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

Guidance for Industry and Food and Drug Administration Staff in March 2016, the requirement for endotoxin testing became universal in the medical device industry.  This change was not as straightforward as expected.

This workshop will provide an overview of endotoxin testing, its history, the current status and expectations of the FDA, and the establishment of current limits, as well as an interactive discussion on the new guidance, the current impact, and what may be coming.


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