Regulatory

12
May

Part 9: Remote Digital Pathology Guidance | COVID-19

  Remote Digital Pathology Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Remote Digital Pathology guidance? Expand access to remote digital pathology devices. Facilitate the remote reviewing and reporting of pathology slides. Reduce healthcare personnel contact and reduce COVID-19 exposure risk. What medical device types are covered by this guidance? Digital Pathology

Read more

12
May

Part 8: Imaging Systems Guidance | COVID-19

  Imaging Systems Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Imaging Systems guidance? Leverage current mobile radiological products and facilitate imaging systems changes for portable use so patients can undergo such procedures without entering a large healthcare facility. Enable updates to current image software that can provide radiological findings to healthcare

Read more

12
May

Part 7: Fetal & Maternal Monitoring Guidance | COVID-19

  Fetal & Maternal Monitoring Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Fetal & Maternal Monitoring guidance? Expand capability of currently marketed non-invasive fetal and maternal monitoring devices. Enable remote monitoring outside healthcare facilities to reduce COVID-19 exposure risk. What medical device types are covered by this guidance? One fetal doppler

Read more

11
May

Part 6: FDA Psychiatric Digital Health Guidance | COVID-19

  Psychiatric Digital Health Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Psychiatric Digital Health guidance? Digital health technologies may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. These technologies may facilitate “social distancing” by reducing contact with providers and can ease the

Read more

11
May

Part 5: FDA Remote Ophthalmic Assessment Guidance | COVID-19

  Remote Ophthalmic Assessment Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 ECMO Bypass Devices guidance? Remote connectivity and analysis would facilitate telemedicine treatment of patients. Modified Ophthalmic devices may be able transmit patient parameters to providers remotely. Some devices may be able to analyze parameters and alert providers to disease state/severity.

Read more

11
May

Part 4: FDA Ecmo Bypass Device Guidance | COVID-19

  ECMO Bypass Device Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 ECMO Bypass Devices guidance? COVID-19 can trigger acute respiratory failure and/or acute cardiopulmonary failure. Extracorporeal oxygenation for greater than 6 hours may be essential treatment. Modified Cardiopulmonary bypass (CPB) devices may expand availability of EMCO therapy. What medical device types

Read more

11
May

Part 3: FDA Infusion Pumps & Accessories Guidance | COVID-19

  Infusion Pumps & Accessories Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Infusion Pumps and Accessories guidance? COVID-19 patients may require continuous infusion of medications, nutrition, and/or other fluids. It is necessary to increase access to an adequate supply of devices to treat these patients. New technologies help protect providers by

Read more

11
May

Part 2: FDA Ventilators & Other Respiratory Devices Guidance | COVID-19

  Ventilators & Other Respiratory Devices Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Ventilators & Other Respiratory Devices guidance? COVID-19 affected patients may develop respiratory failure or respiratory insufficiency; It is necessary to maintain an adequate supply of devices to treat these patients. What medical device types are covered by the

Read more

8
May

Part 1: FDA Remote Monitoring Guidance | COVID-19

  Remote Monitoring Guidance Navigating the Regulatory Pathway during a Global Pandemic What are the motivations for the COVID-19 Remote Monitoring guidance? Leverage patient monitoring technology to help eliminate unnecessary patient contact; Ease the increased healthcare burden of diagnosis and treatment of patients with COVID-19; Provide patient monitoring for conditions unrelated to COVID-19 remote from healthcare facilities. What eight medical

Read more