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FDA recognizes ISO 14971:2019 as consensus standard

  • Home  >  Risk Management  >  FDA recognizes ISO 14971:2019 as consensus standard
  • MedSysCon Medizintechnik GmbH, ISO 14971:2019, Risk Management
    23 Feb

    FDA recognizes ISO 14971:2019 as consensus standard

    Risk Management

    Third Edition gets recognized

    On Jan 14, 2020 the US FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD products ( see: FDA Recognized Consensus Standards ).

    Transition Period

    The transition period of the previous standard edition, ISO 1497:2007, will last through late 2022. Therefore, any declarations of conformity to ISO 14971:2007 included in medical device and IVD premarket submissions will be accepted by the FDA until December 25, 2022.

    Afterwards a medical device submission requires a declaration of conformity to the latest edition ISO 14971:2019.

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