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FDA recognises the ISO 14155:2020 as a consensus standard

January 13, 2021

On December 21st 2020 FDA added ISO 14155:202 on the list of Recognised Consensus Standards. Worth noting is that the FDA highlights its application for post-market clinical investigations: “the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).”

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