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The Mammography Quality Standards Act (MQSA) was enacted by the United States Congress to regulate the quality of care in mammography. The act was officially effective in 1994, and was extended in 2004 to continue through 2007. The U.S. Food and Drug Administration (FDA) began inspections of mammography facilities to ensure compliance in 1995 ...
The 1992 Mammography Quality Standards Act (MQSA) required all mammography facilities to be accredited as meeting quality standards. In 1997, the Food and Drug Administration Modernization Act (FDAMA) created the “least burdensome” approach to encourage FDA staff and industry to use the minimum amount of information to address regulatory ...
Some specific applications, such as the use for primary mammography interpretation, are additionally regulated [12] within the scope of the Mammography Quality Standards Act. The Society for Imaging Informatics in Medicine (SIIM) is the worldwide professional and trade organization that provides an annual meeting and a peer-reviewed journal to ...
iCAD Receives FDA Approval for Digital CAD with Philips Digital Mammography System FDA Approval Provides Radiologists with Expanded Access to Next Generation CAD Platform NASHUA, N.H.--(BUSINESS ...
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
Mammography (also called mastography; DICOM modality: MG) is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast for diagnosis and screening. The goal of mammography is the early detection of breast cancer, typically through detection of characteristic masses, microcalcifications, asymmetries, and distortions.
(Reuters) -The U.S. FDA said on Thursday it has classified a recall of Philips' medical imaging machines as most serious due to the risk of a detector in some devices unexpectedly falling on ...
Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act. [citation needed] From these legal authorities, CBER publishes regulations which are included in the first chapter Title 21 of the Code of Federal Regulations. Most ...