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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 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 ...
In 2019, the FDA first proposed new rules for breast cancer screenings that would require health care providers to give women more information about the risks associated with dense breasts. In ...
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 ...
Big changes are coming to mammogram results — and it could help with screening breast cancer.. The U.S. Food and Drug Administration stated that starting Tuesday, Sept. 10, people will get ...
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 ...
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
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 ...