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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...
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For the most uptodate version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6 New Search Help7 | More About 21CFR 8 [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2015] [CITE: 21CFR314.50] TITLE 21FOOD AND DRUGS CHAPTER IFOOD AND DRUG ADMINISTRATION
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
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