U.S. FDA: Enforcement Policy for Imaging Systems During the COVID-19 Public Health Emergency

FDA: Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency This link will redirect you to the U.S. Food and Drug Administration: Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency webpage. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy- imaging-systems-during-coronavirus-disease-2019-covid-19-public-health- emergency?utm_campaign=2020-04-23%20COVID- 19%20Imaging%20Systems&utm_medium=email&utm_source=Eloqua The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Dis- ease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support re- sponse efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability and capability of medical x-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) expo- sure to COVID-19 for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020. DISCLAIMER By selecting launch, you will be leaving PEPconnect and redirected to a third party webpage. Siemens Healthineers shall have no liability for the contents of such third party web pages and their lawfulness and does not endorse such web pages or their contents as its own. Siemens is neither the provider nor reseller nor legal manufacturer of the offered resource. Any claims made for this resource are under the sole responsibility of the provider. Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Job Aid Effective Date: 19/MAR/2020 Healthineers Job Aid | Insert Title of Job Aid Effective Date: XX/XX/XXXX | HOOD/HILS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Job Aid Effective Date: XX/XX/XXXX | HOOD/HILS Healthineers Page 2 of 2