October 18, 2018
“Since the FDA’s oversight of mammography facilities was established more than 25 years ago, we’ve seen significant advances in the quality and standardization of mammograms,” said FDA Commissioner Scott Gottlieb, M.D. “Mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact medical device innovations have in supporting women’s health. Our forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the increased use of digital imaging devices; revised screening recommendations from CDC and others; the need for more uniform, nation-wide breast density reporting in lieu of the patchwork of reporting requirements that has been implemented in various states; and the increasing clinical value of breast density information in informing medical practice and effective patient care. We believe this proposal will have significant health benefits given its potential to provide women and health care providers with more consistent, comprehensive, scientifically relevant information about mammography results. It will also help to strengthen the FDA’s ability to enforce consistent quality standards for mammograms. The agency is committed to advancing this proposed rule to further empower American patients and providers to make informed health decisions and benefit from innovative mammography services.”
The Office of Management and Budget has indicated it is reviewing a proposed rule from the Food and Drug Administration to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). The MQSA authorizes federal oversight of the more than 8,000 mammography facilities operating in the U.S., including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.
The FDA intends to propose a new rule that will modernize mammography quality by recognizing new technologies, making improvements in facility processes and updating reporting requirements. The agency is proposing updates that incorporate current science and mammography best practices, including addressing breast density reporting by mammography facilities to patients and health care providers. These updates are intended to improve the delivery of mammography services.
The FDA believes there are tremendous public health benefits to this rule, including the potential for earlier breast cancer detection, improved morbidity and mortality, resulting in reductions in cancer treatment costs, and allowing for more informed decision-making by strengthening the communication of health care information between patients and their providers.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.