WEBView the PDF for 21 CFR Part 820; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
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CFR - Code of Federal Regulations Title 21 - Food and Drug …
WEBDec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. § 820.20 - Management...
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21 CFR Part 820 - PART 820—QUALITY SYSTEM REGULATION
WEBDec 22, 2023 · Medical Devices. Databases. The information on this page is current as of Dec 22, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations...
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CFR - Code of Federal Regulations Title 21 - Food and Drug …
WEBDec 22, 2023 · [Code of Federal Regulations] [Title 21, Volume 8] [CITE: 21CFR820.250] TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER...
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Quality System (QS) Regulation/Medical Device Current Good
WEBJan 31, 2024 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21...
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CFR - Code of Federal Regulations Title 21 - Food and Drug …
WEBDec 22, 2023 · [CITE: 21CFR820] TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER H - MEDICAL DEVICES. PART 820. QUALITY SYSTEM...
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Current Good Manufacturing Practice Final Rule; Quality System
WEBCGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), which was among the ...
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21 CFR Part 820 Subpart B -- Quality System Requirements
WEBTitle 21. Chapter I. Subchapter H. Part 820. Subpart B. Previous. Next. Top. Enhanced Content. View table of contents for this page. Subpart B—Quality System Requirements. § 820.20 Management responsibility. ( a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.