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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 054 Date of Entry 07/06/2020 
FR Recognition Number 14-548
Standard
USP 42-NF37:2019 <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 42-NF37:2019 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests.

3. USP 42-NF37:2019 <151> Pyrogen Test (USP Rabbit Test).

4. Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, Issued June 2012.
FDA Technical Contact
 Steven Turtil
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6305
  steven.turtil@fda.hhs.gov
Standards Development Organization
USP United States Pharmacopeial Convention, Inc. http://www.usp.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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