New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines
AGAWAM, MASS. —October 24, 2012 — A new white paper is
available to assist medical device manufacturers with understanding recent changes
to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin
testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.
Titled “FDA Updates Medical Device Endotoxin Testing Program (New
Guidance),” the new white paper is authored by Steven G. Richter, Ph.D., a former FDA
official, and President and Chief Scientific Officer of Microtest Laboratories,
Inc., a leading contract testing laboratory.
In the paper, Dr. 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Endotoxin Guidelines — now considered out of date as a result of changes in the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 his new white paper, Dr. 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
•
In vitro fertilization catheters
Download a copy of the new white paper, “FDA Updates Medical Device Endotoxin Testing Program (New
Guidance),”
from the Microtest Laboratories website at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.
Or, request a copy by calling 1-413-786-1680
or toll-free 1-800-631-1680.
About Microtest Laboratories
Microtest Laboratories is a full-service medical device testing
laboratory and provider of related services for the medical device,
pharmaceutical, and biotechnology industries. Medical device testing is
performed in-house by seasoned regulatory microbiologists and chemists under
strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified.
Testing services include bioburden, sterility, endotoxin, accelerated aging,
and toxicity (ISO 10993). In addition, Microtest recently introduced a
fast-track test to screen plastics and polymers in medical devices for toxicity
using Zebrafish embryos.
Based in Agawam, Massachusetts, USA, the company provides
expertise and flexible processes that enhance product safety and security,
accelerate time to market, and minimize supply chain disruption. For more
information, visit http://www.microtestlabs.com, or call
1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.
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Labels: endotoxin, endotoxin testing, FDA, Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers, manufacturers, Medical Devices
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