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