Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021 

FR Recognition Number

14-570

Standard

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   FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/   240-402-7667   Aprajita.Garg@fda.hhs.gov

Poulomi Nandy   FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/   301-796-7048   Poulomi.Nandy@fda.hhs.gov

Standards Development Organization

USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/

FDA Specialty Task Group (STG)

Sterility

*These are provided as examples and others may be applicable.