FDA Updates Medical Device Endotoxin Testing Program (New Guidance)

A white paper by Steven Richter, Ph.D., Accuratus Lab Services

Recently, the U.S. Food and Drug Administration (FDA) published its new endotoxin guidance document, replacing their 1987 Endotoxin Guideline. The new document indicates that the 1987 guidelines were out of date as a result of changes in the USP and pharmaceutical dosage forms.

The guidance document, issued in June, explains the FDA’s current thinking regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics, and medical devices. Devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The white paper educates the reader about the new FDA guidance document and explains the guidelines as they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, this paper will focus on those contaminates.
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