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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 053 Date of Entry 12/23/2019 
FR Recognition Number 5-125
Standard
ISO  14971 Third Edition 2019-12
Medical devices - Application of risk management to medical devices
Identical Adoption
ANSI AAMI ISO 14971: 2019
Medical devices - Applications of risk management to medical devices
Scope/Abstract
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
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*
ISO/TR 24971 Second edition 2020-06 Medical devices - Guidance on the application of ISO 14971

AAMI/ISO TIR24971: 2020 Medical devices - Guidance on the application of ISO 14971

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
 Melissa Torres
  FDA/OC/CDRH/OCD/
  301-796-5576
  melissa.torres@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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