『FDA QSR改定について』

2018年、FDAは医療機器品質システムに関する規制(21CFR Part820 QSR/Quality System Regulations)をISO13485:2016に整合させることを発表していた。
これまでに発表されていた計画では、2019年春に新ルールの提案(proposed rule)を発出し、2020年に13485:2016に整合させた規制へ移行する予定であった。
しかしながら本計画は現在、COVID-19等の影響で遅れている。
2020年9月時点においては、新ルールの提案は2020年10月になる予定であるとFDAのShuren氏がRAPS(Regulatory Affairs Professional Society)との会合において述べた。

FDAのShuren氏は会合においてさらに以下のように述べている:
「QSRの13485:2016との整合は依然としてCDRHにとって優先度の高い事項だが、COVID-19への対応に集中しなければならなかったことから皆様が想像できるように、同じ程度の取り組みをすることができなかった他の多くの事項がある。
したがって、ISO 13485規制を発行できるようになるまでには、もうしばらくかかると予想している」

「ISO13485規制の実装に関しては、移行の時間を設ける。
ただし、提案されたルールを公開する時点で、パブリックコメントを取得し、
レビューして、最終的なルールを公開する必要がある。
したがって、新提案のルールによって、FDAが何を計画しているかがわかる。
これは、人々が適切な変更を開始するための出発点となるはずである」

詳しくはこちら

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