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Whitepaper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

A new whitepaper is available to assist medical device manufacturers with understanding recent changes to the Food and Drug Administration (FDA)'s thinking regarding endotoxin testing. The paper is available to download from the Web at

Titled “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” the new white paper is authored by Steven G. Richter, PhD, a former FDA official and president and chief scientific officer of Microtest Laboratories, Inc., a leading contract testing laboratory.

In the paper, Richter discusses the FDA’s recently published document, “Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers.” The FDA document replaced the agency’s 1987 Endotoxin Guidelines — now considered out of date as a result of changes in the USP and pharmaceutical dosage forms. It presents the agency’s current position regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics and medical devices. Medical 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.

In the new whitepaper, Richter reviews the FDA’s updated guidelines on endotoxin testing and explains how they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, the paper focuses on those contaminates.

Some medical devices that are required by the FDA to be tested for endotoxin are: intravenous catheters and tubing, cardiac stents and angioplasty balloons, certain implants such as pacemakers/defibrillators, spinal catheters, transfusion catheters, intraocular lens implants, cranial drills, perfusion tubing, dialysis tubing and filters, vascular grafts, and in vitro fertilization catheters.

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