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FDA Proposes Policy Changes to Improve Mammography Quality Standards

Kristi Rosa
Published: Wednesday, Mar 27, 2019

For the first time in 20 years, the FDA has proposed amendments to key policies to modernize breast cancer screening and improve mammography services, in order to enable healthcare providers and patients to make more informed medical decisions.1

Other notable policy changes that the agency suggested, but are not limited to:
  • The FDA should be provided with the ability to directly contact patients and providers if a mammogram failed to meet quality standards and to inform them of the possibility that they may need to go for another test at a different certified facility;
  • To modernize quality standards, facilities should only use digital accessory components that have received regulatory approval or clearance for mammography;
  • Bolstered requirements for record-keeping are needed to improve access to and transfer of mammography records and to reduce loss of information;
“While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their healthcare professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.



  1. FDA Advances Landmark Policy Changes to Modernize Mammography Services and Improve Their Quality. FDA. Published March 27, 2019. Accessed March 27, 2019.
  2. Engmann NJ, Golmakani MK, Miglioretti DL, et al. Population-attributable risk proportion of clinical risk factors for breast cancer. JAMA Oncol. 2017;3(9):1228-1236. doi: 10.1001/jamaoncol.2016.6326.

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