FDA Guidance on Pyrogen and Endotoxin Testing

Detected March 19th, 2026

Summary

The FDA has issued guidance for biological product, drug, and device firms regarding pyrogen and endotoxin testing. This document provides recommendations based on current FDA thinking concerning USP and AAMI standards for bacterial endotoxin and pyrogen tests.

View original document View source feed page

What changed

This guidance document from the FDA provides recommendations for biological product, drug, and device manufacturers on current FDA thinking regarding pyrogen and endotoxin testing. It references and aligns with United States Pharmacopeia (USP) Chapter <85> and <161>, as well as Association for the Advancement of Medical Instrumentation (AAMI) ST72, detailing test methodologies and acceptance criteria.

While this guidance is non-binding, it outlines the FDA's current expectations for testing to ensure product safety. Manufacturers should review the referenced USP and AAMI standards to ensure their testing protocols align with FDA recommendations. Comments on this guidance can be submitted via docket ID FDA-2013-S-0610.

What to do next

Review FDA guidance on pyrogen and endotoxin testing.
Ensure testing protocols align with referenced USP and AAMI standards.
Submit comments via docket ID FDA-2013-S-0610 if applicable.

Source document (simplified)

Search for FDA
Guidance Documents

Issued by: Guidance Issuing Office Center for Veterinary Medicine Human Foods Program 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 <85> “ Bacterial Endotoxins Test”, USP Chapter <161> “ Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, 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.

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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