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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 14-570
USP-NF M98830_02_01
<85> Bacterial Endotoxins Test
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where endotoxin testing is a component of the development, manufacture, and/or release of the product.
Relevant FDA Guidance and/or Supportive Publications*
1. ANSI/AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

2. USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests.

3. USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test).

4. Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, Issued June 2012.

5. DOI: https://doi.org/10.31003/USPNF_M98830_02_01.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Aprajita Garg
 Poulomi Nandy
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.