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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-185
Standard
CLSI  M41-A
Viral Culture; Approved Guideline.
Scope/Abstract
This document provides guidance for viral culture and identification procedures performed in the clinical virology laboratory.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Multiple (All CFR citation related to viruses, and the procodes related to the device types listed above)
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 Contact
 Evgeniya Volkova
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/VIR2/
  240-402-7454
  evgeniya.volkova@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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