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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.
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 ...
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.
A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...
The Centers for Medicare & Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards.
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)
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [ 1 ] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device: