The U.S. Food and Drug Administration (FDA) has received numerous inquiries about COVID-19 and its increasing impact on mammography facilities. Accordingly, we are providing information about common scenarios that may arise due to the evolving COVID-19 situation in the United States. These scenarios include:
- States that restrict inspector travel or duties
- Facilities that choose to close
- Facilities that continue to operate and need flexibility in the timing of the annual MQSA inspection
- Facilities that cannot schedule an annual medical physicist survey due to circumstances out of their control
- Facilities that continue to operate and have non-compliance citations that are due to circumstances out of their control
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