US: COVID-19 Emergency Use Authorizations for Medical Devices

The secretary of Health and Human Services (HHS) announced that conditions exist in justifying the provision of emergency use of the following during the COVID-19 outbreak pursuant to section 564 of the Act and subject to the terms of any authorization issued under that section:

- Emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19

- Personal Respiratory Protective Devices

- Other Medical Devices (Alternative products used as MD)

There are guidances related to COVID-19 on the Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that CDRH has issued:

- Blood Purification Devices EUAs

- Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs

- In Vitro Diagnostics EUAs

- Infusion Pump EUAs

- Personal Protective Equipment EUAs

- Remote or Wearable Patient Monitoring Devices EUAs

- Respiratory Assist Devices EUAs

- Ventilators and Ventilator Accessories EUAs

- Other Medical Device EUAs

Source: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

Please contact info@arqon.com for more info