Emergency Use Of Unapproved Medical Devices

FAQs on Emergency Use Authorizations (EUAs) for …

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic

A: For medical device EUAs, go to Emergency Use Authorizations for Medical Devices. This page lists current EUAs issued for medical devices during the COVID-19 pandemic as well as...

Expanded Access for Medical Devices | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

Frequently Asked Questions About Medical Devices | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices

This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices …

Authorization of Emergency Use of Certain Medical …

https://www.federalregister.gov/documents/2022/03/22/2022-06008/authorization-of-emergency-use-of-certain-medical-devices-during-covid-19-availability

With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening …

Expanded Access to Unapproved Medical Devices

https://research.virginia.edu/irb-hsr/expanded-access-unapproved-medical-devices

If there is an IDE for the unapproved medical device, the IDE sponsor must notify the FDA of ...

Frequently Asked Questions About Medical Devices

https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf

Unless it is an emergency, before an HUD is used off-label, the agency recommends that the HDE holder obtain FDA approval of the use following the compassionate use policy …

Emergency Use and Compassionate Use of …

https://irb.ucsf.edu/emergency-use-and-compassionate-use-experimental-drugs-and-devices

Emergency Use Request Requirements for Drug or Biologic If the use of an unapproved drug, or biologic can be justified as emergency use, the physician must …

Emergency Use of an Unapproved Drug, Biologic or Device

https://research.ucdavis.edu/policiescompliance/irb-admin/researchers/project-guidance/investigational-drugs-or-devices/emergency-use/

Emergency Use of an Unapproved Drug, Biologic or Device Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life …

Emergency Use of an Unapproved Medical Device or Drug

https://www.rushu.rush.edu/research/office-research-affairs/protection-human-subjects/emergency-use-unapproved-medical-device

Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard …

FAQs on the Emergency Use Authorization for Face …

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-emergency-use-authorization-face-masks-non-surgical

Face masks should NOT be used in place of surgical masks or filtering facepiece respirators to provide protections such as: Liquid barrier protection Antimicrobial or …