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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 14-566
Standard
USP-NF M98795_02_01
<55> Biological Indicators -- Resistance Performance 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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2800 Indicator, Biological Sterilization Process Class 2 FRC
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Issued October 2007.

2. USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization.

3. DOI: https://doi.org/10.31003/USPNF_M98795_02_01.
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.
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