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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Recognition 12/23/2019 
FR Recognition Number 5-125
Standard
ISO 14971 Third Edtion 2019-12
Medical devices - Application of risk management to medical devices
U.S. 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.
Transition Period
FDA recognition of ISO 14791 Second Edition 2007-03-01 [Rec# 5-40] will be superseded by recognition of ISO 14791 Third edition 2019-12 [Rec# 5-125]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-40] until December 25, 2022. After this transition period, declarations of conformity to [Rec# 5-40] will not be accepted.
FDA Technical Contact
 Melissa Torres
  FDA/OMPT/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)
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