FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Moves to Improve Mammography Quality Standards

March 29, 2019
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The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found.

The agency plans to require that only digital accessory components specifically FDA approved or cleared for mammography be used in mammography facilities, or that facilities use components that otherwise meet the requirements in the rule.

In other proposed changes, the agency would directly notify patients and healthcare professionals that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed, if the facilities themselves are unwilling or unable to notify them.

In addition, the rule would strengthen record-keeping requirements to minimize information loss and improve access to patient mammography records.

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