FDAがISO14971:2019をConsensus Standardとして認知した。
今後、承認申請において2007年版は2022年12月25日まで受け入れる。
それ以降は2007年版の使用は認めない。
詳しくはこちら。
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- ISO-14971:2019 医療機器
- FDAがISO-14971を認知規格に指定
FDAがISO14971:2019をConsensus Standardとして認知した。
今後、承認申請において2007年版は2022年12月25日まで受け入れる。
それ以降は2007年版の使用は認めない。
詳しくはこちら。
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