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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.
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.
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 rule is promulgated at 21 CFR 820. [ 5 ] According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in ...
For example, in the US, the Food and Drug Administration have regulations in Part 21 of the Code of Federal Regulations. [54] Nash et al. have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes. [ 55 ]
Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) [8] and Title 21 CFR Part 11. [9] Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes.
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 ...
FDA Regulation 21 CFR Part 11 - Electronic Records; Electronic Signatures (1997) FDA announcement 08-July-2010 (21 CFR Part 11) General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002) FDA Guidance for Industry Part 11, Electronic Records: Electronic Signatures – Scope and Application (2003)