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FDAnews Device Daily Bulletin

FDA Issues Mammography Compliance Notice

Aug. 8, 2016

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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