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Improving Health Through Medical Physics


  • FDA Update on Manufacturer Filing of Reports of Assembly for Diagnostic X-Ray Equipment
    FDA will allow assemblers of diagnostic X-ray systems to discontinue submitting Reports of Assembly (Form 2579) to FDA. Purchasers (and state regulatory agencies, where applicable) must still be provided with these reports within 15 days following completion of assembly.
    View FDA Policy on Imaging Systems During COVID-19
  • 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.
    View Guidance
  • 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