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Improving Health Through Medical Physics

FDA

  • FDA guidance for modification of approved imaging systems to address needs related to COVID-19
    “…to help ensure the greatest possible number of products for medical imaging are available to address healthcare needs during the public health emergency, FDA does not intend to object to limited modifications to the indications, technical specifications, functionality, hardware, software,or materials of the identified FDA-cleared or FDA-approved imaging systems that are used todiagnose and/or monitor medical conditions (hereinafter referred to as “subject products”), or to limited modifications to the indications or functionality of image analysis software to address urgent COVID-19 image analysis needs during the declared public health emergency where such modification does not create an undue risk, without prior submission of a premarket notificationunder section 510(k)…”
    View FDA Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • 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
    View Press Release
  • MQSA Inspection Information Related to COVID-19
    The MQSA provides a description of policy and inspection information and modifications in response to the COVID-19 pandemic. This includes extensions to the annual survey.
    View Site
  • AAPM Letter to the FDA
    View Letter