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USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices

Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564" and "Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency" for comments.


Section 564 Declaration: Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows the FDA to authorize the emergency use of medical products during public health emergencies.

Emergency Use Authorization (EUA): An EUA allows the use of unapproved medical products or unapproved uses of approved medical products during emergencies.

Public Health Emergency: These are situations where there is an urgent public health need for certain IVDs, but a declaration under Section 564 of the FD&C Act has not been made.


FDA is issuing this draft guidance to describe the factors that the FDA intends to consider when deciding whether to issue an enforcement policy when a future declaration of an emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is issued. Check out this guidance to know the Factors that you need to Consider in Deciding Whether to Issue an Enforcement Policy for Unapproved Tests.


This draft guidance describes FDA's enforcement policy for laboratory manufacturers offering certain unauthorized in vitro diagnostic devices in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act when responding immediately to chemical, biological, radiological, or nuclear agents. This draft guidance aims to ensure the government's coordinated and effective response to an emergent situation in the event of a disaster.


The scope of the guidance and the types of IVDs covered, including diagnostic tests, serological tests, and other tests used to diagnose or detect the presence of a specific pathogen or condition. By following this guidance, manufacturers can ensure compliance with FDA regulations and standards, thereby ensuring the safety and effectiveness of diagnostic tests used in response to public health emergencies.



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