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Expanded Access for Medical Devices | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices
- What is Emergency Use?Emergency use is when there is a need to use a device that has not received th…Criteria for Emergency Use1. The patient has a life-threatening condition that needs immediate tre… See more
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 …
Expanded Access to Unapproved Medical Devices
- https://research.virginia.edu/irb-hsr/expanded-access-unapproved-medical-devices
- Unapproved medical device: is a device that is utilized for a purpose, condition, or use for ...
Displaying Investigational and Unapproved Medical …
- https://www.mddionline.com/news/displaying-investigational-and-unapproved-medical-devices-according-fda-policy
- However, the agency has stated in an unpublished writing that such a device may be brought into the country if certain conditions are met. 6 First, the device must be …
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