jueves, 19 de marzo de 2020

MQSA Inspection Information Related to COVID-19



MQSA Inspection Information Related to COVID-19

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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