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Before the FDA ruling, 39 states and Washington D.C. had state mandates that required mammogram facilities to notify patients about their breast density or inform them about breast density, in ...
The FDA's new rules released Thursday essentially set a minimum amount of information mammogram providers will be required to tell women. It "provides uniform guidance," Burstein said, because "it ...
The new FDA changes require facilities to provide patients with information about their breast density and include specific language in the mammogram result letter to explain how breast density ...
HB 2102, also known as "Henda's Law", is a breast density (BD) notification law approved in 2011 by the FDA that mammography patients be provided educational materials on dense breast tissue can hide abnormalities, including breast cancer, from traditional screening. Henda's Law aims to promote patient–doctor discussion as well as reduce the ...
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 ...
Women age 40 and older in every state are now receiving notifications about their breast density along with their standard mammogram report, due to a new rule from the Food and Drug Administration.
In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). Former leaders of CDRH [15] Jeffrey Shuren, M.D., J.D., CDRH Director 2009 – 2024; Daniel Schultz M.D., CDRH Director 2004 – 2009
Starting Tuesday, Sept. 10, 2024, all mammogram facilities across the country will be required to notify patients about the density of their breasts as part of updated mammography regulations ...