FDA がQSRの改定案を発表

QSRからQMSR（Quality Management Regulation）へ

FDAは、医療機器の品質システム規制を調和させ、近代化する方針である。今回の改訂では、既存の要求事項を、医療機器製造に関する国際的なコンセンサス規格であるISO 13485:2016の仕様に置き換える予定である。この改訂は、国内外の要件を調和させることにより、機器製造業者のコンプライアンスおよび記録管理の負担を軽減することを目的としている。また、この改訂は、規制を近代化するものである。

FDAは、21 CFR Part 820 品質システム規則（QSR）の現行適正製造基準（cGMP）要件を、国際的に認知されているISO 13485:2016 医療機器 – 品質管理システム – 規制目的の要求事項とより密接に整合させるための修正を提案している。この改正案は、21 CFR Part 4 組み合わせ製品の規制にも影響を与える。FDAを含む5つの規制当局が協力して開発した医療機器単一監査プログラム（MDSAP）は、CGMP要件の調和に向けた実用性をさらに実証している。FDAは、現在の規制の枠組みを他の規制当局と調整して、「機器規制の一貫性を促進し、患者のために安全で効果的かつ高品質な機器のタイムリーな導入を実現する」ことを望んでいる。

背景

21 CFR Part 820に基づく医療機器のcGMP要件は、連邦食品・医薬品・化粧品法（FD&C）第520条(f)により初めて認可されたものである。FD&C法のセクション520(f)に基づき、FDAは医療機器のcGMP要件を発行した。これは1978年に発効し、21 CFR Part 820に体系化された。

FDA は 1997 年に cGMP 要件を改訂し、安全医療機器法 (SMDA) によって承認された設計管理を追加した。 FDAは、cGMP規制がISO 9001:1994 Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicingの要件と一致することが、公衆および医療機器業界にとって有益であると考えたのである。1997年以降、21 CFR Part 820に大きな変更はない。

ISO 13485の初版は1996年にリリースされ、タイトルは「ISO 13485:1996 品質システム-医療機器-ISO 9001の適用に関する特定の要求事項」であった。第1版は、ISO 9001:1994規格からの最初の移行版であった。ISO 13485の第2版は2003年にリリースされ、タイトルはISO 13485:2003 医療機器 – 品質管理システム – 規制目的の要求事項であった。第3版となる現行版は「13485:2016」である。ISO 13485がリリースされるたびに、要求事項は21 CFR Part 820のcGMPの要求事項に近づき、より整合性のあるものとなっている。

変更案

FDAは、ISO 13485:2016 品質管理システム – 規制目的の要求事項（現行版）を参照することにより組み込むことを提案している。ISO 13485の改訂または更新は、1 CFR Part 51 Incorporation by Referenceで要求されるように、承認前にその影響を判断するために評価する必要がある。参照により組み込まれた場合、結果として生じる規則は品質管理システム規則（QMSR）と呼ばれることになる。

FDAは、21 CFR Part 820とISO 13485:2016の要求事項は「実質的に類似」しており、ISO 13485:2016との相違点が特定された場合、その意図と目的は21 CFR Part 820の要求事項と「概ね一致」すると考えている。21 CFR Part 820とISO 13485：2016の規制が融合した後、組み合わせ製品を含む医療機器の安全性と有効性が同じレベルで提供できるとFDAは信じている。

FDAは21 CFR Part 820の合理化を進めており、ISO 13485:2016の要求事項を修正せずに受け入れるか、対応するISO 13485:2016の要求事項に優先する要求事項を提案する予定である。表 1 は、21 CFR Part 820 の規則案の相違点と追加事項の大まかな要約である。

現行の part 820.1ISO 13485要求事項1規則案
サブパートA-総則条項1.適用範囲、条項4.品質マネジメントシステム要求事項は実質的に類似。
サブパートB-品質システム要求事項条項4.品質管理システム、条項5.経営者の責任、条項6.資源の運用管理、条項8.測定、分析、および改善要求事項は実質的に類似。
サブパートC-設計管理条項7.製品実現要求事項は実質的に類似。
サブパートD—文書管理条項4.品質マネジメントシステム820.35で対処された違い。
サブパートE-購買管理条項7.製品実現要求事項は実質的に類似。
サブパートF-識別およびトレーサビリティ条項7.製品実現要求事項は実質的に類似。
サブパートG-製造および工程の管理条項4.品質管理システム、条項6. 資源の運用管理、条項7.製品実現要求事項は実質的に類似。
サブパートH-受入れ活動条項7.製品実現、条項8. 測定、分析、および改善要求事項は実質的に類似。
サブパートI-不適合品条項8.測定、分析、および改善要求事項は実質的に類似。
サブパートJ-是正処置および予防処置条項8.測定、分析、および改善要求事項は実質的に類似。
サブパートK-包装およびラベリングの管理条項7.製品実現820.45で対処された違い。
サブパートL-取扱い、保管、流通、および据付け条項7.製品実現要求事項は実質的に類似。
サブパートM-記録条項4.品質マネジメントシステム820.35で対処された違い。
サブパートN-付帯サービス条項7.製品実現820.35で対処された違い。
サブパートO-統計的手法条項7.製品実現、条項8.測定、分析、および改善要求事項は実質的に類似。
表 1: 21 CFR Part 820規則案の相違点と追加点の概要

1 この表は、要求事項ごとの分析を意図したものではなく、参照のみを目的として、ISO 13485:2016 と 21 CFR Part 820 のサブパートおよび条項全体の上位レベルのマッピングを意図したものである。

2 ここで重要なのは、サブパートDで特に特定された相違点がある一方で、ISO 13485:2016および21 CFR Part 820のほとんどのサブパートおよび条項に文書要件が存在することである。

より詳細なマッピングについては、AAMI技術情報レポートAAMI TIR102:2019 U.S. FDA 21 CFRとISO 13485:2016「品質マネジメントシステム」の該当する規制要件リファレンスのマッピングを参照すること。注 AAMI TIR102:2019は、現行の21 CFR Part 820をISO 13485:2016にマッピングしており、医療機器品質システム規制を修正する提案を考慮していない。

820.1     適用範囲

FDAは、21 CFR Part 820の対象となる事業所や製品を変更することを提案していない。この要件は、完成品の製造業者に適用されるが、FDAは、完成した機器のコンポーネントまたは部品の製造業者、委託滅菌業者、設置業者、再ラベル業者、再製造業者、再梱包業者、または仕様開発業者、および外国企業の最初の販売業者を対象とする法的権限が存在することを指摘している。

要件の適用範囲に関する修正には、より具体的で相反する規制は、相反する範囲に限って優先されることを明確にしたものが含まれる。

820.3 定義

21 CFR Part 820 からの交換

  • (n) ISO 9000:2015 3.1.1 の執行責任を伴うトップマネジメント。

21 CFR Part 820 から削除

  • (j) 機器マスター レコード (DMR) とは、完成した機器の手順と仕様を含む記録の編集を意味し、ISO 13485:2016 4.2.3 医療機器ファイルの要件を使用する。

21 CFR Part 820から引き継ぐ予定

  • (a) 法とは、改正後の連邦食品・医薬品・化粧品法 (Secs. 201-903, 52 Stat. 1040 以降、修正されたもの (21 U.S.C. 321-394)) を意味する。同法第 201 条のすべての定義は、本パートの規則に適用されるものとする。
  • 保持 (b) 苦情とは、配布用にリリースされた後のデバイスのアイデンティティ、品質、耐久性、信頼性、安全性、有効性、または性能に関する欠陥を申し立てる、書面、電子的、または口頭でのコミュニケーションを意味する。
  • (c) コンポーネントとは、完成、パッケージ化、およびラベル付けされた機器の一部として含まれることを意図した原材料、物質、部品、部品、ソフトウェア、ファームウェア、ラベリング、またはアセンブリを意味する。
  • (l)完成した機器とは、パッケージ化、ラベル付けまたは滅菌されているかどうかにかかわらず、使用に適した、または機能することができる機器または機器の付属品をいう。
  • (o)製造業者とは、完成機器の設計、製造、加工、組立、または処理を行うすべての者をいう。製造業者には、委託滅菌、設置、再ラベル付け、再製造、再梱包、または仕様開発の機能を実行する者、およびこれらの機能を実行する外国の事業体の最初の販売業者が含まれるが、これらに限定されない。
  • (q) 不適合とは、特定の要求事項を満たしていないことを意味する。
  • (r) 製品とは、コンポーネント、製造材料、製造中のデバイス、完成したデバイス、および返品されたデバイスを意味する。
  • (w) 再製造業者とは、完成したデバイスの性能または安全仕様、あるいは意図された用途を大幅に変更する処理、調整、改修、再梱包、復元、またはその他の行為を行う者をいう。
  • 再製造者とは、完成機器の性能または安全仕様、あるいは意図された用途を大幅に変更する加工、調整、改修、再梱包、復元、またはその他の行為を行う者をいいます。
  • (x) リワークとは、不適合品を流通させる前に、指定された DMR 要求事項を満たすために行う処置のことである。
  • (z) (1) プロセスバリデーションとは、あるプロセスが所定の仕様を満たす結果または製品を一貫して生産することを、客観的な証拠によって立証することである。
  • (z) (2) 設計の妥当性確認とは、機器の仕様がユーザのニーズ及び意図された用途に適合していることを客観的な証拠によって立証することである。
  • (aa) 検証とは、指定された要求事項が満たされていることを検査し、客観的な証拠を提供することによって確認することである。
  • (bb) 機器として規制されるヒト細胞、組織、または細胞もしくは組織を基にした製品（HCT/P）とは、本章1271.3（d）に定義されるHCT/Pで、1271.10（a）の基準を満たさず、また機器として規制されるものを意味する。

21 CFR Part 820 から用語を変更

  • (p) 製造材料はこれからプロセスエージェントになる。

21 CFR Part 820 または ISO 13485:2016 のいずれにもない新しい用語

  • 顧客とは、ユーザを含む個人または組織を意味し、この個人または組織が意図または必要とする製品またはサービスを受け取る可能性がある、または受け取ることができる人を意味する。顧客は、組織の内部であっても外部であってもよい。

FD&C法に抵触するため、ISO13485:2016からは採用されない予定である。

  • 3.4 苦情
  • 3.8 ラベリング
  • 3.11 医療機器

820.7 リスクマネジメント

この要件により、品質マネジメントシステム（QMS）プロセス全体を通じて、リスクマネジメント活動およびリスクに基づく意思決定がより重視されることになる。機器製造業者にとってのリスクマネジメントとは、製造する機器の安全性と有効性を確保するために、製品のライフサイクルを通じてリスクを特定、分析、評価、制御、監視する本質的な体系的実践である。

820.10 品質管理システム

これは、ISO13485の要求事項に準拠した品質マネジメントシステムを確立し、維持することを製造業者に求めるものである。

条項 7.3 設計及び開発は、クラスII及びIIIの機器並びに特定のクラスIの機器にのみ適用される。

埋め込み型医療機器に関する条項 7.5.9.2 は、生命を維持・支援する機器、またはラベルに記載された使用説明書に従って適切に使用された場合の機能不全が、重大な傷害につながることが合理的に予想される機器に適用される。

820.15 概念の明確化

FDAは、「組織」という用語が、製造業者820.3(o)の意味も含むことを明確にすることを提案している。

FDAは、ISO13485:2016が安全性と性能を使用している場合、その表現は安全性と有効性と同じ意味とすることを提案している。

FDA は、ISO 13485:2016 で使用されているプロセスのバリデーションという用語を、プロセスのバリデーション 820.3(z)(1)) を意味するものとして明確にすることを提案している。

820.35 記録の管理

FDAは、記録（紙および電子）の有効性を確保するためにFDAが必要とする情報を明確にするため、ISO 13485:2016 条項 4.2.5 記録の管理の対象記録に署名および日付の要件を含めることを提案する。

FDA は、21 CFR Part 803 Medical Device Reporting で要求される情報が、苦情およびサービス活動の特定の記録に確実に含まれるようにするための具体的要件を提案している。

企業は、21 CFR Part 830 Unique Device Identification に従って、各医療機器または医療機器のバッチの Unique Device Identification (UDI) を記録に文書化することが要求される。

保持 21 CFR 820.180 一般要求事項 (a) 機密性。製造業者によって機密とみなされた記録は、本章パート 20の情報公開規制の下で情報を開示してもよいかどうかをFDAが判断するのに役立つように、マークを付けることができる。

820.45 デバイスのラベリングとパッケージング

安全で効果的な機器の製造をより確実にするため、検査要件を含むラベリングおよび包装管理に関する現行のISO 13485:2016の要件を強化する。

発効日および実施方針

この提案に基づく最終規則は、製造業者がQMSを適切に分析・更新し、FDAがその職員を適切に訓練する時間を確保するため、連邦官報に最終規則が掲載された日から1年後に発効することをFDAは提案している。

本提案が採択された場合、FDA の査察は通常通り継続される。FDAの査察によってISO 13485への適合証明書が発行されることはなく、FDAがISO 13485の認証プログラムを開発することもない。さらに、ISO 13485への適合証明書を持つ製造業者は、FDAの査察を免除されることはない。

質問

この提案された規則について質問がある場合は、Proposed-Device-QMSR-Rule@fda.hhs.gov に電子メールを送信すること。

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形　医療機器関連” ]

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