Ads
related to: fda 21 cfr 820.30
Search results
Results From The WOW.Com Content Network
Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30).
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.
The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices. [40] Subpart B includes quality system requirements, an important component of which are design controls (21 CFR 820.30).