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Medical Devices / QSR

FDA Issues Mammography Compliance Notice

Aug. 8, 2016
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When mammography facilities are found to be noncompliant with quality standards, the FDA can require the facility to perform a patient and provider notification.

The facility will receive a letter citing the reasons for the PPN action and instructions to complete to become compliant, the FDA said in a notice issued July 27.

The facility is assigned a compliance officer to guide it through the actions it needs to take to become compliant. The agency will then track the notification procedures and audit the facility. — Tamra Sami

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