How to Submit a Pre-EUA for In vitro Diagnostics to FDA
Pre-EUA information for manufacturers of IVD tests
This page is intended for manufacturers of in vitro diagnostic (IVD) tests.
One way FDA helps enable access to medical countermeasures (MCMs), such as in vitro diagnostic (IVD) tests, is through Emergency Use Authorizations (EUAs). An EUA allows FDA to authorize use of an unapproved MCM, in anticipation of a potential emergency or during an actual emergency involving a chemical, biological, radiological, or nuclear agent, or emerging infectious disease, if certain criteria are met. You can find a list of current EUAs, along with the supporting declarations, on our Emergency Use Authorization page. Also see: Emergency Use Authorizations (current device EUAs)
To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration. Please note that a pre-EUA can only transition to an EUA if there is a current applicable emergency declaration.
Are you interested in submitting a Pre-EUA for an IVD test for a pathogen with a current EUA declaration?
If so, FDA recommends the following steps:
Email CDRH-EUA-Templates@fda.hhs.gov and request a copy of the most recent EUA review template relevant to your test.
Please include a brief description of your IVD (target pathogen, device technology – assay based on molecular, antigen or antibody detection, etc.).
After you receive the EUA review template, populate the draft template with the information and data that you currently have for your IVD test.
Send the draft template back to FDA for review as a Pre-EUA submission using the instructions that are provided along with the EUA review template (which includes sending 1 hard copy and 1 electronic copy to the Document Control Center).
The Pre-EUA review is a very interactive process. The draft review template is a shared “work-in-progress” document which you will populate with information and data about your test. FDA will review and provide feedback to you.
Are you interested in submitting a Pre-EUA for an IVD test for a pathogen that does not have a current EUA declaration?
If so, FDA is interested in learning about your IVD test from a biopreparedness perspective and recommends the following steps:
Email Device@fda.hhs.gov to express your interest.
Please include in the email the following information about your device:
A detailed description of your IVD (target pathogen, device technology - assay based on molecular, antigen or antibody detection, etc.)
The proposed Intended Use
Summary of any analytical (LoD, inclusivity, exclusivity, Interfering substances, Hook effect, etc.) and clinical data collected for this device to date
Summary of any analytical or clinical studies planned but not yet started
On receipt of this request FDA will contact you and outline the specific steps for submitting a Pre-EUA for your IVD test.
If you are not sure which Pre-EUA process to follow, have a non-diagnostic device you would like considered for a Pre-EUA or have additional device-related questions with respect to EUA, contact Device@fda.hhs.gov. If you have general device-related questions that are not specific to EUA, we recommend you consult our Device Advice: Comprehensive Regulatory Assistance webpage that includes contact information for the Division of Industry and Consumer Education (DICE).
If you are interested in Pre-EUA discussions for another product (such as a therapeutic or biological product), or have general questions about EUAs, contact EUA.OCET@fda.hhs.gov.
- Coronavirus Disease 2019 (COVID-19)
- FAQs on Diagnostic Testing for SARS-CoV-2
- Zika Virus Diagnostic Development – includes information on Zika reference materials available from FDA for NAT-based IVD devices and serological tests
- Guidance: Emergency Use Authorization of Medical Products and Related Authorities