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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 051 Date of Entry 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*
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
 Lisa Simone
  FDA/OC/CDRH/OSPTI/ORR/DAHPR/
  301-796-2591
  Lisa.Simone@fda.hhs.gov
 Binoy Mathews
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6475
  Binoy.Mathews@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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