FDA Pyrogen and Endotoxins Testing Q&A

Date

March 23, 2026

Category

US Regulations

Description

In March 2026 the FDA published edition 2 of their Q&A on Pyrogen and Endotoxins Testing, which updates the previous version published in June 2012.  See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-questions-and-answers

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.