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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 036 Date of Entry 07/09/2014 
FR Recognition Number 13-15
Standard
CLSI AUTO13-A2 (Formerly GP19-A2)
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
Scope/Abstract
Identifies important factors that designers & laboratory managers should consider when developing new software-driven systems & selecting software user interfaces. Also included are simple rules to help prepare validation protocols.
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 Contact
 James Mullally
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/TB/
  240-402-5021
  james.mullally@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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