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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 051 Date of Recognition 01/14/2019 
FR Recognition Number 13-105
Standard
ANSI AAMI SW91:2018
Classification of defects in health software
Scope/Abstract
This standard provides a common language for the classification of defects occurring in health software.

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.
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Lisa Simone
  FDA/OMPT/CBER/OBRR
  301-796-2591
  Lisa.Simone@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Software/Informatics
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