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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 020 Date of Entry 09/09/2008 
FR Recognition Number 13-19
Standard
CLSI  LIS04-A
Standard Guide for Documentation of Clinical Laboratory Computer Systems
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
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
 Yan Zhang
  CDRH/OPEQ/OHTVII/DMGP/MGB
  301-837-7386
  yan.zhang1@fda.hhs.gov
 Thomas Miller
  CDRH/OPEQ/OHTVII/DCTD/CB
  240-402-8938
  Thomas.Miller@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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