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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 051 Date of Entry 01/14/2019 
FR Recognition Number 7-178
Standard
CLSI  M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
Scope/Abstract
This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media.
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
§866.2300 Culture Media, Non-Selective And Non-Differential Class 1 JSG
§866.2320 Culture Media, Multiple Biochemical Test Class 1 JSE
§866.2320 Culture Media, Single Biochemical Test Class 1 JSF
§866.2320 Culture Media, Non-Selective And Differential Class 1 JSH
§866.2330 Culture Media, Enriched Class 1 KZI
§866.2350 Media, Culture, Amino Acid Assay Class 1 JRZ
§866.2350 Culture Media, Antibiotic Assay Class 1 JSA
§866.2350 Culture Media, Vitamin Assay Class 1 JSB
§866.2350 Culture Media, General Nutrient Broth Class 1 JSC
§866.2360 Culture Media, Selective Broth Class 1 JSD
§866.2360 Culture Media, Selective And Differential Class 1 JSI
§866.2360 Culture Media, Selective And Non-Differential Class 1 JSJ
§866.2410 Culture Media, For Isolation Of Pathogenic Neisseria Class 2 JTY
Relevant FDA Guidance and/or Supportive Publications*
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
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Robyn AtkinsonDunn
  CDRH/OPEQ/OHTVII/DMD/BAC1/
  --
  robyn.atkinsondunn@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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