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
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 · CFR - Code of Federal Regulations Title 21. 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...
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21 CFR §820 Quality System Regulation - Code of Federal Regulations
WEBThe Electronic Code of Federal Regulations. Title 21. Displaying title 21, up to date as of 4/25/2024. Title 21 was last amended 4/15/2024. view historical versions. Title 21. Chapter I. Subchapter H. Part 820. Subpart A. § 820.1. Previous. Next. Top. § …
WEB( a) General. ( 1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. ( 2) The following class I devices are subject to design controls:
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eCFR :: 21 CFR Part 820 Subpart I -- Nonconforming Product
WEBTitle 21. Displaying title 21, up to date as of 4/25/2024. Title 21 was last amended 4/15/2024. view historical versions. Title 21. Chapter I. Subchapter H. Part 820. Subpart I. Previous. Next. Top. eCFR Content. Enhanced Content. View table of contents for this page. Subpart I—Nonconforming Product. § 820.90 Nonconforming product.
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CFR - Code of Federal Regulations Title 21 - Food and Drug …
WEB[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...