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GUIDANCE DOCUMENT

Pyrogen and Endotoxins Testing: Questions and Answers June 2012

Final

Pyrogen and Endotoxins Testing: Questions and Answers

Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
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Rockville, MD 20852

All comments should be identified with the title of the guidance.