FDA Updates Regulations on Mammography

Interviewer: Lauri R. Graham; Interviewee: David D. Lee, MD


June 14, 2019

Editorial Collaboration

Medscape &

Proposed Report Content

What other information will the reports now include?

Minimum standards of information about the facility location are to be communicated to healthcare providers. For example, we propose to require expanded information about the mammography facility, including the name and location (ie, city, state, and zip code) to facilitate better communication with and about that facility. This may be helpful for healthcare providers to be able to more readily identify the facility if their patients have any questions regarding their mammogram study.


Let's pivot to the issue of thermography . A recent safety communication from the FDA warns that it should not be used as an alternative to mammography. Could you briefly talk about that?

While this proposed amendment relates to mammography and does not cover thermography, we advise patients that there is no evidence to support the use of thermography for breast cancer screening . Mammography is the best primary screening method, proven to reduce deaths from breast cancer through earlier detection. People who substitute thermography for mammography may miss the chance to detect cancer at its earliest stages. Thermography has high rates of both false-positive and false-negative results. Incorrect information produced by thermography may result in a delayed cancer diagnosis.


You mentioned regulations with respect to facilities. What happens with state laws?

The MQSA already explicitly states that nothing in the statute shall be construed to limit the authority of any state to enact and enforce state laws that are at least as stringent as the MQSA. That will also apply to the breast density reporting requirement.

How does this affect mammography being done in mobile mammography units that might be used in rural areas or elsewhere?

Under the MQSA, the regulatory requirements are the same for mobile units and stationary units, with the additional requirement that each time a mobile unit moves, a post-move verification test must be performed before it is used for imaging. Like stationary units, mobile units must be accredited by an FDA-approved accrediting body. Any mobile unit must have a certificate issued by the FDA or an FDA-approved certifying agency. The proposed amendment does not change this requirement.

Also, as it is currently, if a facility is found to have provided mammography services that are not of acceptable quality, the FDA can require the facility to perform what is called a patient and provider notification, in which the facility must contact patients and healthcare providers who may have been impacted and may need either repeat imaging or re-evaluation of their original mammogram studies. In the case that a facility is not able or willing to perform this notification, the FDA puts out public safety notices that can be targeted to a specific geographic location. With the proposed update to the regulations, however, the FDA would be expressly allowed to directly communicate with patients and healthcare providers.

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