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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 14-564
USP-NF M98910_01_01
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
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.
Relevant FDA Guidance and/or Supportive Publications*
1. Consult the technical contacts regarding recommendation for orthopedic products, medical and surgical gloves, or wound dressings.

2. ANSI/AAMI ST72:2011/(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

3. USP-NF M98830_02_01 <85> Bacterial Endotoxins Test.

4. USP-NF M98900_01_01 <151> Pyrogen Test.

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

6. DOI: https://doi.org/10.31003/USPNF_M98910_01_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.