Pre-EUA-Interactive-Review-Template

Pre-Emergency Use Authorization (EUA)/EUA
Interactive Review Template
For Non-IVD Products
This interactive review template (the “template”) was designed to capture the
data/information needed by the Food and Drug Administration (FDA) to support
authorization of a product for emergency use during the COVID-19 pandemic. This
template is intended to help companies provide the information to FDA, but alternative
approaches can be used. For more information about EUAs in general, refer to the FDA
Guidance document: Emergency Use Authorization of Medical Products and Related
Authorities. Once completed, please send this interactive review template to [email protected].
GENERAL INFORMATION ABOUT THIS TEMPLATE
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Text highlighted in yellow [text] should be completed by the medical device product
developer (“sponsor”) as applicable to its specific product. Text in bold outlines the
FDA’s suggestions and clarifications for the sponsor to consider when completing the
information in each section.

•

This is a template for Pre-EUA/EUA submissions and not a guidance document. It
includes the information that FDA recommends be included in such submissions, as
outlined in the Emergency Use Authorization of Medical Products and Related
Authorities Guidance document. This template is subject to change as we learn more
about COVID-19 generally or improve the EUA review process.

•

Any trade secret or confidential commercial information provided within the template
and during the interactive review process will remain confidential.

•

Feedback provided by FDA during the interactive review of a pre-EUA/EUA
submission is subject to change as FDA gains experience during an emergency, and
as FDA learns more about the disease/condition this device addresses.

•

Please remember that if an EUA is issued for your product, the authorization would
only be for the use specified in the EUA and subject to the conditions in the EUA.
This device must not be introduced into interstate commerce for uses outside the
authorized use without obtaining marketing clearance, approval, IDE, or another
EUA by the FDA.

•

Clinical data may be required to support an EUA request. Please note that human
subject protection requirements (21 CFR Part 50) apply to clinical trials conducted to
support an EUA.

Pre-EUA/EUA Interactive Review Template (for Non-IVD Products)

Updated 5/12/20

•

If authorized, the EUA means that the product would be authorized for use until the
declaration of public health emergency is terminated, or the EUA is revoked by the
FDA.

•

The EUA is not a pathway to permanent marketing of your product. For
information on premarket submissions, refer to FDA’s website on “How to Study and
Market Your Device” at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/how-study-and-market-your-device. For
guidance on modifications that trigger the requirement that a manufacturer submit a
new premarket notification (510(k)) to FDA, refer to FDA guidance Deciding When
to Submit a 510(k) for a Change to an Existing Device.

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Pre-EUA/EUA Interactive Review Template (for Non-IVD Products)

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Pre-EUA/EUA Interactive Review Template
For Non-IVD Products
A. PURPOSE FOR SUBMISSION
Emergency Use Authorization (EUA) request for distribution and/or use of the [Name of
Medical Device Product (“product”)] to indicate end user(s) (e.g., patients, hospitals);
brief summary of intended use for product (e.g., prevention/diagnosis /treatment); and
description of the intended patient population]
B. APPLICANT
Applicant information:
• Applicant Company Name:
• Applicant Address:
• Applicant Contact Person:
• Applicant Contact Phone#:
• Applicant Contact Email:
Correspondent information (if different from the Applicant):
• Correspondent Company Name:
• Correspondent Address:
• Correspondent Contact Person:
• Correspondent Contact Phone#:
• Correspondent Contact Email:
C. PROPRIETARY AND ESTABLISHED NAMES
Proprietary Name - [product trade name]
Established Name - [generic name]
D. INTENDED USE
1) Proposed Intended Use of the Product
[Include the proposed intended use for the product that is subject of this request.]
The intended use will be finalized based on the data and recommendations at the
time of authorization.
2) Special Conditions of Use Statements:
[Include any special conditions of use statements to be included in the product
labeling, e.g., “For prescription use only” and other specific conditions]

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Pre-EUA/EUA Interactive Review Template (for Non-IVD Products)

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E. REGULATORY INFORMATION
1) Marketing authorization in the U.S.
Previous regulatory submissions (including application number) [510(k), De
Novo, PMA, HDE, IDE]:
[Include any prior regulatory history for this product. Indicate whether the product
is legally marketed in the US. If so, include the premarket submission number(s).
If applicable, include a description of any modifications made to the legally
marketed product.]
[If no prior clearances or approvals, including under an investigational product
exemption (IDE) application, include the following statement:
The [Name of Product] is not cleared or approved for introduction into interstate
commerce nor subject to an approved IDE application.]
Pending application(s) currently under review:
[Indicate whether the product has any pending regulatory submission with FDA.]
2) Marketing authorizations in any other country:
Indicate whether the product currently has marketing authorization in another
regulatory jurisdiction, such as the European CE Mark, Australian Register of
Therapeutic Goods (ARTG) Certificate of Inclusion, Health Canada License, or
Shonin approval from the Ministry of Health, Labour, and Welfare in Japan, and
attach any relevant documentation, such as the marketing authorization letter or
certificate, or corresponding information such as the certificate of conformity.
F. PRODUCT DESCRIPTION AND PRINCIPLE
[Include a detailed description of the product.] Please note that for new technologies FDA
may request additional detailed information so we can adequately assess the known and
potential risks and benefits associated with the product.
1) Product Overview/Product Principle:
[Describe the technology of the [Type of Product] and how this technology
works to [include intended use] the [pathogen/disease/condition].]
2) Detailed Description of Product Use:
[List and describe in detail all the steps involved in using the product. Include a
detailed description of how the end user uses the product; capture the key product
description information related to the product function.]
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3) Applicable Standards
[Indicate whether the product has been designed, evaluated, and validated in
accordance with the applicable FDA-recognized standards.]
4) [Include Any Other Important Topics Necessary to Describe the Product]:
[If applicable, include additional sections concerning other topics about the
product design and use that are important to capture, for example if calibration of
the product is required, or special features of the product. This section may also
include literature provided to support the intended use. Otherwise, indicate this
section is N/A.]
G. PRODUCT MANUFACTURING AND PLANNED DISTRIBUTION
[Include a detailed description of the product manufacturing and distribution. ]
1) Overview of Manufacturing and Distribution:
[Include an overview of the manufacturing and planned distribution of the
product. Include where the product will be manufactured, including whether it
will be manufactured inside the United States or manufactured outside the United
States and then imported.]
2) Quality System
[Indicate whether the product is manufactured in compliance with 21 CFR Part
820 or ISO 13485: Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes, or an equivalent quality system, and the
manufacturer or importer has documentation of such.]
3) Components Included with the Product
[List all components provided with/for your product].
4) Other Components Not Included with the Product
[List all components not included with the product that should be supplied by the
user to use the product, with specific supplier names and catalog numbers,
product characteristics, or other identifiers for obtaining these components.
5) [Other Important Topics to Describe]:
[If applicable, include additional sections concerning other topics about the
product manufacturing that are important to capture. Otherwise, indicate this
section is N/A.]
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6) Product Stability/Shelf Life:
Briefly describe the stability/shelf-life test plan for the product and include any
accelerated stability/shelf life information (if available). Briefly describe any
standards used to evaluate product stability/shelf-life (e.g., ASTM F1980).
H. EVIDENCE OF POTENTIAL EFFECTIVENESS
[During Interactive Review, you may be requested to provide line item data, protocols
and reports to support that the product may be effective.]
[Include data (including bench, animal and/or clinical) you have collected to support the
emergency use of your product.]
I. APPROVED/CLEARED ALTERNATIVE PRODUCTS
[FDA and/or the Sponsor can provide a summary of the currently approved/cleared
alternative products. If appropriate, sponsors can use the following statement:]
Currently no methods for the [prevention/diagnosis/treatment] of the
[pathogen/disease/condition] have been approved/ cleared by FDA.
J. UNMET NEED ADDRESSED BY THE PRODUCT
[This section will be finalized by FDA based on the state of the emergency at the time of
authorization and based on recommendations from public health authorities at that time.
Include an explanation of the unmet need of the product.]
A public health emergency has been declared by the Secretary of Health and Human
Services (HHS) on [Month Day, YEAR] justifying the authorization of emergency use of
[Type of Product] for [state the intended use of the product].
The [product name] can [outline how product can aid in the public health response].
Under emergency use authorization (EUA), [applicant name] plans to distribute the
[product name] for the [prevention/diagnosis/treatment] of [pathogen/disease/condition]
in individuals meeting CDC’s [pathogen/disease/condition] clinical and/or
epidemiological criteria. This EUA request for the [product name] is intended to expand
domestic readiness within the United States and its territories by expanding
[prevention/diagnosis/treatment] capabilities for [pathogen/disease/condition] during
public health emergency.
FDA consulted with subject matter experts within HHS on the public health needs for
[Type of Product] to [prevent/diagnose/treat] the [pathogen/disease/condition]. It is
FDA’s conclusion that there currently exists a public health need for such products, i.e.,
that there is no adequate, approved (cleared), and available alternative to the [product

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Pre-EUA/EUA Interactive Review Template (for Non-IVD Products)

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name] for [pathogen/disease/condition] [prevention/diagnosis/treatment] during the
public health emergency.
K. RISKS AND BENEFITS:
Update this section according to your specific product, some example language is given
below but should be tailored to the product and the disease.
[This is a key section of the EUA Interactive Review Template that outlines the riskbenefit analysis. Fill out this section based on your risk-benefit analysis, however, there
may be other key elements that FDA may request based on its review of the information
provided.
Risks
The known and potential risks of the [product name] are:
• [X]
o [X]
Benefits
The known and potential benefit of the [product name] for clinical use [X] are:
• [X]
o [X]
[Include a discussion on the criterion related to known and potential benefits outweighing
known and potential risks, taking into consideration the material threat posed by COVID19.]
L. FACT SHEET FOR HEALTHCARE PROVIDERS AND PATIENTS
[Include proposed Fact Sheets for Patients and Healthcare Providers. Sponsors are
encouraged to review other Fact Sheets on the CDRH EUA Website as examples.]
M. INSTRUCTIONS FOR USE/ PROPOSED LABELING/PACKAGE INSERT
[Include Instructions for Use, Box Labels, Product Labels and any other proposed
labeling.]
N. RECORD KEEPING AND REPORTING INFORMATION TO FDA:
[Include a description of the record keeping and reporting for the product. Example
language is provided below.]
[Manufacturer name] will track adverse events and report to FDA. A website is
available to report on adverse events, and this website is referenced in the Fact Sheet for
Health Care providers as well as through the [Manufacturer name] Product Support
website: [Include link to Website]. Each report of an adverse event will be processed
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Pre-EUA/EUA Interactive Review Template (for Non-IVD Products)

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according to [Manufacturer name]’s Non-Conformance Reporting Requirements, and
Medical Device Reports will be filed with the FDA as required. Through a process of
inventory control, [Manufacturer name] will also maintain records of product
usage/purchase. [Manufacturer name] will collect information on the performance of the
[product], and report to FDA any suspected occurrence of product malfunctions of which
[Manufacturer name] becomes aware. [Manufacturer name] will maintain records
associated with this EUA and ensure these records are maintained until notified by FDA.
Such records will be made available to FDA for inspection upon request.
O. FDA SUMMARY OF DOCUMENTATION AND REVIEW [for FDA Internal
Use Only]
[FDA reviewers will include a brief summary of the documentation provided and their
conclusion of whether the product meets the EUA criteria outlined in section 564 of the
Food, Drug, and Cosmetic Act. The FDA reviewer should include a statement regarding
the known and potential benefits from the use of the [product name] for [intended use of
the product under this EUA] are expected to outweigh the known and potential risks.
FDA reviewers should clearly distinguish their comments and edits in the document from
the information provided by the sponsor.]
P. INTERACTIVE REVIEW LOG:
Use the table below to document interactive review, include interactions initiated by
either FDA or the sponsor.
Date
[X]

Type of Interaction
(phone/ email/ formal
submission-DCC)
[X]

Brief Description (e.g., questions asked/ feedback from
FDA received / any word documents included)
[X]

Q. NEXT STEPS:
Once FDA review is completed, FDA will notify the sponsor regarding the status of the
pre-EUA/EUA. Please note that, as set forth in FDA’s guidance Emergency Use
Authorization of Medical Products and Related Authorities, FDA intends to prioritize its
review of EUA requests during a declared emergency based on various factors, including
the extent to which the product would serve a significant unmet medical need.
R. FINALIZING REVIEW
Once FDA review is completed, FDA reviewers should finalize the documentation, sign
and date the Interactive Review Template (which will serve as the FDA review memo for
the pre-EUA/EUA), and document concurrence from the OHT management.

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