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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
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.
Device Master Record. A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.
Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30. The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device.
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
Quality management system. A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1] It is expressed as the organizational goals and aspirations, policies ...
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.