Draft Guidance Emergency Use Authorization Of Medical Products

Emergency Use Authorization of Medical Products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities

This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two …

Emergency Use Authorization of Medical Products and …

https://www.federalregister.gov/documents/2016/04/04/2016-07478/emergency-use-authorization-of-medical-products-and-related-authorities-draft-guidance-for-industry

Guidance and Other Information of Special Interest to …

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/guidance-and-other-information-special-interest-mcm-stakeholders

January 2017: Guidance - Emergency Use Authorization of Medical Products and Related Authorities - This guidance finalizes the draft guidance, …

FAQs: What happens to EUAs when a public health …

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends

For medical devices, FDA issued a draft guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus …

Transition Plan for Medical Devices Issued Emergency Use …

https://www.federalregister.gov/documents/2021/12/23/2021-27891/transition-plan-for-medical-devices-issued-emergency-use-authorizations-during-the-coronavirus

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health …

Transition Plan for Medical Devices Issued Emergency …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-during-coronavirus-disease

GUIDANCE DOCUMENT. Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID …

Emergency Use Authorization of Medical …

https://www.federalregister.gov/documents/2017/01/13/2017-00721/emergency-use-authorization-of-medical-products-and-related-authorities-guidance-for-industry-and

The guidance represents the current thinking of FDA on emergency use authorization of medical products and related authorities. It does not establish any …

Draft Guidance; Emergency Use Authorization of Medical …

https://www.federalregister.gov/documents/2005/07/05/05-13121/draft-guidance-emergency-use-authorization-of-medical-products-availability

The Food and Drug Administration (FDA) is announcing the availability of draft guidance entitled “Emergency Use Authorization of Medical Products.” The draft …

Technical Considerations for Demonstrating Reliability of …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-demonstrating-reliability-emergency-use-injectors-submitted-under-bla-nda

The term “emergency-use injector” means injectors marketed with an emergency-use drug as a prefilled single entity combination product under 21 CFR …

Search for FDA Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for …