Emergency Use Unapproved Medical Devices

Expanded Access for Medical Devices | FDA

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

During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or …

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 …

Frequently Asked Questions About Medical Devices

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

and Emergency Use of Unapproved Medical Devices (September 1998) Office of Health Affairs, Food and Drug Administration. This document was revised to make it …

Emergency Use and Compassionate Use of …

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

Use of an investigational drug, biological product, or medical device generally requires either an IND (for unapproved drugs and biologics) or an IDE (for …

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 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 acceptable treatment is …

Expanded Access to Unapproved Medical Devices

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

NOTE: An emergency use DOES NOT require IRB Concurrence or FDA approval BEFORE use. Unapproved medical device: is a device that is utilized for a purpose, condition, or …

Expanded Access to Unapproved Medical Devices - UCI …

https://research.uci.edu/human-research-protections/clinical-research/devices-used-in-clinical-research/expanded-access-to-unapproved-medical-devices/

There are two parts to this application. First, a new protocol application for emergency use must be completed prior to the emergency use of the unapproved device. The IRB …

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

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

A: The FDA received questions about the original face mask EUA posted on April 18, 2020. On April 24, 2020, the FDA updated and re-issued the EUA to clarify that face masks, …