Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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13-15
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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 |
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Scope/AbstractIdentifies 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. |
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Extent of Recognition
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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
|
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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. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Groups (STG)
Software/Informatics (primary) |
InVitro Diagnostics |
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*These are provided as examples and others may be applicable. |