合衆国法典(USC)に収められる、食品・医薬品・医療機器・化粧品などに関する規制を定めた法律です。
Subchapter Vで「Drugs and Devices (医薬品及び医療機器)」について定められており、Part A「Drugs and Devices (医薬品及び医療機器)」のSection 351 ~ 360n-2で、製造業者の登録、市販後調査や報告などについて規定されています。
主に医療機器にも関係するものを青字、医療機器には主に関係しない条項はグレーで表示しています。
FDCA# | USC# | タイトル |
---|---|---|
Sec. 501 | Sec. 351 | Adulterated drugs and devices(不良医薬品及び医療機器) |
Sec. 502 | Sec. 352 | Misbranded drugs and devices(不正商標表示医薬品及び医療機器) |
Sec. 503 | Sec. 353 | Exemptions and consideration for certain drugs, devices, and biological products(特定の医薬品、医療機器及び生物学的製剤に関する免除及び考慮事項) |
Sec. 503A | Sec. 353a | Pharmacy compounding(薬局調剤) |
Sec. 503B | Sec. 353b | Outsourcing facilities(アウトソース施設) |
Sec. 503C | Sec. 353c | Prereview of television advertisements(テレビCMの事前審査) |
Sec. 503D | Sec. 353d | Process to update labeling for certain generic drugs(特定のジェネリック医薬品におけるラベリング更新の手続き) |
Sec. 504 | Sec. 354 | Veterinary feed directive drugs(獣医飼料指令(VFD)医薬品) |
Sec. 505 | Sec. 355 | New drugs(新薬) |
Sec. 505-1 | Sec. 355-1 | Risk evaluation and mitigation strategies(リスク評価・緩和戦略(REMS)) |
Sec. 505-1 | Sec. 355-1 | Risk evaluation and mitigation strategies(リスク評価・緩和戦略(REMS)) |
Sec. 505A | Sec. 355a | Pediatric studies of drugs(医薬品の小児用研究) |
Sec. 505B | Sec. 355c | Research into pediatric uses for drugs and biological products(医薬品および生物由来製品の小児用使用に関する研究) |
Sec. 505C | Sec. 355d | Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers(小児用の計画、評価、延期、延期延長、および免除の審査に関する内部委員会) |
Sec. 505D | Sec. 355e | Pharmaceutical security(医薬品のプロダクトセキュリティー) |
Sec. 505E | Sec. 355f | Extension of exclusivity period for new qualified infectious disease products(新規承認の感染症治療製品に関する独占期間の延長) |
Sec. 505F | Sec. 355g | Utilizing real world evidence(リアルワールドエビデンスの活用) |
Sec. 505G | Sec. 355h | Regulation of certain nonprescription drugs that are marketed without an approved drug application(承認済医薬品申請書なしで販売される特定の非処方薬の規制) |
Sec. 506 | Sec. 356 | Expedited approval of drugs for serious or life-threatening diseases or conditions(重篤または生命を脅かす疾患または状態に対する医薬品の迅速な承認) |
Sec. 506A | Sec. 356a | Manufacturing changes(製造上の変更) |
Sec. 506B | Sec. 356b | Reports of postmarketing studies(市販後研究の報告) |
Sec. 506C | Sec. 356c | Discontinuance or interruption in the production of life-saving drugs(救命薬の製造の中止または中断) |
Sec. 506C-1 | Sec. 356c-1 | Annual reporting on drug shortages(医薬品不足に関する年次報告) |
Sec. 506D | Sec. 356d | Coordination; task force and strategic plan(調整;タスクフォースと戦略計画) |
Sec. 506E | Sec. 356e | Drug shortage list(医薬品不足リスト) |
Sec. 506F | Sec. 356f | Hospital repackaging of drugs in shortage(不足医薬品の病院での再包装) |
Sec. 506G | Sec. 356g | Standards for regenerative medicine and regenerative advanced therapies(再生医療・先端再生医療の基準) |
Sec. 506H | Sec. 356h | Competitive generic therapies(競合ジェネリック医薬品) |
Sec. 506I | Sec. 356i | Prompt reports of marketing status(マーケティング状況の迅速な報告) |
Sec. 506J | Sec. 356j | Discontinuance or interruption in the production of medical devices(医療機器の製造の中止または中断) |
Sec. 506K | Sec. 356k | Platform technologies(プラットフォーム技術) |
Sec. 506L | Sec. 356l | Advanced manufacturing technologies designation program(先端製造技術指定制度) |
Sec. 507 | Sec. 357 | Qualification of drug development tools(医薬品開発ツールの適格性評価) |
Sec. 508 | Sec. 358 | Authority to designate official names(正式名称の指定権限) |
Sec. 509 | Sec. 359 | Nonapplicability of subchapter to cosmetics(化粧品へのサブチャプターの非適用) |
Sec. 510 | Sec. 360 | Registration of producers of drugs or devices(医薬品または医療機器の製造者の登録) |
Sec. 511 | Sec. 360a | Clinical trial guidance for antibiotic drugs(抗生物質の臨床試験ガイダンス) |
Sec. 511A | Sec. 360a-2 | Susceptibility test interpretive criteria for microorganisms(微生物の感受性試験解釈基準) |
Sec. 512 | Sec. 360b | New animal drug(動物用新医薬品) |
Sec. 512A | Sec. 360b-1 | Priority zoonotic animal drugs(優先動物原性感染症医薬品) |
Sec. 513 | Sec. 360c | Classification of devices intended for human use(ヒト用医療機器の分類) |
Sec. 514 | Sec. 360d | Performance standards(性能基準) |
Sec. 515 | Sec. 360e | Premarket approval(市販前承認) |
Sec. 515A | Sec. 360e-1 | Pediatric uses of devices(医療機器の小児用使用) |
Sec. 515B | Sec. 360e-3 | Breakthrough devices(革新的医療機器) |
Sec. 515C | Sec. 360e-4 | Predetermined change control plans for devices(医療機器の事前決定変更管理計画) |
Sec. 516 | Sec. 360f | Banned devices(禁止医療機器) |
Sec. 517 | Sec. 360g | Judicial review(司法審査) |
Sec. 517A | Sec. 360g-1 | Agency documentation and review of significant decisions regarding devices(医療機器に関する重要な決定に関する政府機関による文書化と審査) |
Sec. 518 | Sec. 360h | Notification and other remedies(通知その他の救済措置) |
Sec. 518A | Sec. 360h-1 | Program to improve the device recall system(医療機器のリコールシステム改善プログラム) |
Sec. 519 | Sec. 360i | Records and reports on devices(医療機器に関する記録と報告) |
Sec. 520 | Sec. 360j | General provisions respecting control of devices intended for human use(ヒト用医療機器の管理に関する一般規定) |
Sec. 521 | Sec. 360k | State and local requirements respecting devices(医療機器に関する州および地方の要件) |
Sec. 522 | Sec. 360l | Postmarket surveillance(市販後監視) |
Sec. 523 | Sec. 360m | Accredited persons(認定者) |
Sec. 524 | Sec. 360n | Priority review to encourage treatments for tropical diseases(熱帯病の治療を促進するための優先審査) |
Sec. 524A | Sec. 360n-1 | Priority review for qualified infectious disease products(適格な感染症製品に対する優先審査) |
Sec. 524B | Sec. 360n-2 | Ensuring cybersecurity of devices(医療機器のサイバーセキュリティの確保) |
連邦食品医薬品化粧品法のSubchapter V以外の構成については、下記から確認できます。
https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices