21 CFR Part 801 Labeling

Part 801 LABELINGとは

FDAの医療機器のラベリングに関する規則
以下を規定：

  • ラベリングに関する一般的事項
  • UDI
  • OTC機器のラベリング要求
  • 適用除外事項
  • 特定の機器に関するラベリング要求
ラベルとラベリングの違い
  • ラベル（Label）
    あらゆる物品の直接の容器の上における文字、印刷、または図案による表示（The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(k) ）
  • ラベリング（Labeling）
    (1) あらゆる物品、あるいはその容器または包装材に表示される、または(2)これらの品物に付随する、全てのラベル、およびその他の文字、印刷、または図案による表示を含む（The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(m) ）
Part 801 LABELING 　目次
  • Subpart A – ラベリングに関する一般的規定
    • § 801.1 -医療機器; 製造業者、包装業者またはディストリビューターの名称および事業所
    • § 801.3 – 用語の定義
    • § 801.4 – 意図する使用の意味
    • § 801.5 – 医療機器; 使用のための適切な指示
    • § 801.6 – 医療機器; 誤解を招く表現
    • § 801.15 – 医療機器; 必要なラベル記載の顕著性。 ラベリングにおける記号の使用
    • § 801.16 -医療機器; 特定の必須記載事項のスペイン語版
    • § 801.18 – 医療機器ラベルに記載される日付のフォーマット
  • Subpart B – UDIに関するラベリング要求事項
    • § 801.20 – UDIを備えるべきラベル
    • § 801.30 – UDIを備えるべきラベルの要求事項の一般的な例外
    • § 801.35 – UDIを備える機器の任意のラベリング
    • § 801.40 – UDIの形式
    • § 801.45 – UDIのダイレクトマーキングが必要な機器
    • § 801.50 – スタンドアローンソフトウェアのラベリング要求事項
    • § 801.55 – UDI要求事項の除外または代替手段のリクエスト
    • § 801.57 – 機器に割り当てられた従来のFDA識別番号の廃止
  • Subpart C – OTC機器に関するラベリング要求事項
  • Subpart D – 適切な使用説明書の適用除外
  • Subpart E – その他の適用除外事項
  • Subparts F-G [Reserved]
  • Subpart H ? 特定の機器についての特別要求事項
Subpart A – ラベリングに関する一般的規定

Subpart Aでは、全ての医療機器に適用されるラベリング要件を定めている

  • 名称、事業所の住所 (part801.1)
    • 機器のラベルに製造業者、包装業者又はディストリビュータの名称および事業所の住所を記載すること
  • 意図する使用の意（part801.4）
    • 意図する使用とは機器のラベリングに法的責任を持つ者の客観的な意図である。この意図はこのような人による表現によって決定されるか、機器の販売を取り巻く状況によって示される場合がある。
  • 適切な使用方法 （part801.5）
    • 適切な使用方法とは、素人が機器をその意図する目的に沿って安全に使用することを可能とする指示のことである。
  • 誤解を招く表現（part801.6）
    • 誤ったまたは誤解を招く表記は不正表示とみなされる。
  • 必要なラベル記載の顕著性。 ラベリングにおける記号の使用（part801.15）
    • 以下の理由で、単語、表記またはその他の必要な情報について、要求される顕著性を欠いているとされることがある
      • 通常の購買状況において表示されるべき部分又はパネルに記載がない
      • パッケージが十分なスペースを有し、必要な情報が複数のパネル上に記載がなされておらず、それらのパネルが通常の購買の状況において表示のために設計されている場合…etc
Subpart B – UDIに関するラベリング要求事項

Subpart Bでは、機器のUDIに関する事項が規定されている。

  • UDIを備えるべきラベル（part801.20）
    • 全ての医療機器のラベルはＰａｒｔ８０１及び830の要求を満たすＵＤＩを備えること
    • 全ての医療機器の包装はＰａｒｔ８０１及び830の要求を満たすＵＤＩを備えること
    • 例外は801.30,801.45,801.128(f)に記載されている。また、801.55に例外または代替手段のリクエストについて記載されている。
  • UDIを備えるべきラベルの要求事項の一般的な例外（part801.30）
    • (a)一般
      • UDIルール運用開始要求日までの間に製造・ラベルの貼り付けがなされた機器（要求日から3年間の免除）
      • クラスⅠ機器でPart820の適用を除外されている機器　等
    • (b) National Drug Codeが割り振られているコンビネーション製品
    • (c) シッピングコンテナ
    • (d) クラスⅠ機器のPI（製造識別子）の免除
  • UDIを備える機器の任意のラベリング（part801.35）
    • UDI規制の対象外の機器であっても、UDIを備えても構わない。
  • UDIの形式（part801.40）
    • 全てのUDIは830.20に規定する技術的要求を満たすこと
      • 容易に読み取れるプレーンテキストであること
      • AIDC（Automatic Identification & Data Capture,自動認識）技術を使用すること
    • DI（機器識別子）を必ず含むこと。機器のラベルがロットやバッチ番号、製造日、有効期限を含む場合にはそれらの情報を伝えるPI（製造識別子）も含むこと。
    • AIDC技術がラベルや包装の目視検査で明らかに視認できない場合、当該ラベルや包装はAIDC技術を使用していることを明らかにすること。
    • UPC（Universal Product Code）を備えたクラスⅠ機器はSubpart Bの要求を満たしているとみなす。
  • UDIのダイレクトマーキングが必要な機器 （part801.45）
    • 一般：
      • 複数回使用され、使用前に再加工されることを意図された医療機器は機器それ自体にUDIを備えなければならない
    • ダイレクトマーキング用のUDI
      • ダイレクトマーキング用のUDIは当該機器のラベル・包装上に記されたものと同一で良い
      • 包装されていない機器を当該機器を含む機器パッケージと区別するために、当該機器に異なるUDIを用いても良い
    • ダイレクトマーキング用UDIの形式
      • 容易に読み取れるプレーンテキストであること
      • 要求されるUDIを提供できるAIDC技術またはその他の技術を使用すること
  • UDIのダイレクトマーキングが必要な機器 （part801.45）
    • 例外：以下のいずれかに当てはまる機器はダイレクトマーキングの例外
      • ダイレクトマーキングが機器の安全性や有効性を妨げるもの
      • ダイレクトマーキングが技術的に実現不可能であるもの etc
    • DHFへの例外についての記載
      • 上記の例外を用いると決めた場合、ラベラーはDHFに判断の根拠を文書化しなければならない
  • スタンドアローンソフトウェアのラベリング要求事項（part801.50）
    • パッケージの形で流通しないスタンドアローンソフトウェアについては、part801.50(b)(次のbullet point記載事項)を満たし、当該ソフトウェアのPIにおいてバージョン番号を示しているならば、UDIラベリング要求を満たすとみなす
    • パッケージの形での流通有無を問わず、医療機器規制を受けるスタンドアローンソフトウェアは以下のどちらかまたは両方の形でUDIを備えなければならない：
      • 容易に読み取れるプレーンテキストのステートメントがソフトウェア起動時に表示される
      • 容易に読み取れるプレーンテキストのステートメントがメニューコマンドを通じて表示される
    • パッケージおよびパッケージでない形の両方で流通するスタンドアローンソフトウェアは同一のDI（機器識別子）で識別されること
  • UDI要求事項の除外または代替手段のリクエスト（part801.55）
  • 機器に割り当てられた従来のFDA識別番号の廃止（part801.57）

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