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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 059 Date of Entry 12/19/2022 
FR Recognition Number 13-124
Standard
AAMI  CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
Scope/Abstract
This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971. It does not modify the ISO 14971 risk management process - rather it provides information and guidance to inform the application of ISO 14971 to ML medical technology. A risk management process is further detailed in Annex A. This document addresses the same types of risk that are addressed in ISO 14971 but focuses on risks that are elevated with or unique to ML medical devices. Because artificial intelligence (AI) and ML are software-driven, the unique or elevated risks are those around data management, feature extraction, algorithm training, evaluation, and cyber and information security. This document also provides examples and suggests strategies for eliminating or mitigating the associated risk.
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 Contact
 Kenny H. Cha
  CDRH/OSEL/DIDSR
  301-795-2858
  kenny.cha@fda.hhs.gov
Standards Development Organization
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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