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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 14-568
Standard
USP-NF  M98800_01_01
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration 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. USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.

2. USP-NF M98810_01_01 <71> Sterility Tests.

3. DOI: https://doi.org/10.31003/USPNF_M98800_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 Contact
 Yongqing Chen
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB
  240-402-9433
  Yongqing.Chen@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.
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