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Improving Health Through Medical Physics



  • FDA guidance regarding MQSA inspections during the pandemic
    The FDA has issued updated guidance regarding MQSA inspections during the pandemic, recognizing operational challenges including difficulties scheduling annual medical physicist surveys. As the FDA prepares to resume routine inspections, the guidance offers continued flexibility to facilities and an easing of enforcement for some of the facility inspection requirements of the MQSA.
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  • All FDA inspections temporarily postponed, including MQSA inspections
    Press Release - Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
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  • MQSA Inspection Information Related to COVID-19
    FDA intends to automatically grant a two-month extension (from the FDA recommended 14-month timeframe) for the facility to complete the annual survey. A request for an extension does not need to be filed with FDA.For any circumstance due to coronavirus which the facility cannot control and that could lead to non-compliance citations, the facility should be prepared to provide detailed documentation.Facilities that choose to cease operations due to the coronavirus should document the period in which they are not performing mammography and ensure all required quality control testing is performed prior to resuming operations. This includes the annual medical physicist survey or other quality assurance duties which may have been required during the closure period.
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