Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders | Guideline Explorer

Description

1.Preparedness and Response2.Information Recommendations3.Format of Submissions4.FDA Processing of an EUA Request

Scope & Applicability

Product Classes

10

Medical Countermeasures

MCMs stockpiled for CBRN emergencies

diagnostic device

Section 564(m) allows FDA, if issuing an EUA for a diagnostic device, to indicate testing settings.

MCMs

Medical Countermeasures for public health emergencies

IVD medical devices

In vitro diagnostic medical devices requiring EUA

IVD

Example 6: In vitro diagnostic for Candida species susceptibility

MCM

Medical Countermeasures; In some cases, administration of an MCM may go hand-in-hand with dispensing the MCM.

Unapproved animal drugs

New authorities added by the 21st Century Cures Act

In Vitro Diagnostics

Diagnostic devices with specific clinical data needs

Personal Protective Equipment

categorized as medical devices within MCMs

In Vitro Diagnostic

IVD device clinical studies conducted on de-identified specimens

Stakeholders

10

Commissioner

Decision maker in expedited withdrawal procedures; Provides opportunity for a meeting or written appeal during withdrawal procedures.; FDA Commissioner or their designee presiding over appeals

licensed health care professionals

involved in the dispensing of product

government stakeholders

responsible for determining when to commence emergency dispensing

licensed practitioner

it may not be practicable for each person to interact with a licensed practitioner before receiving a product.

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

health care professionals

Users of medical software functions

Secretary of HHS

Authority who declares public health emergencies

authorized dispensers

Responders who administer MCMs under an EUA; Fact Sheets are recommended for health care professionals or authorized dispensers.; authorized dispensers may be responsible for dispensing or administering some or all MCMs.; Personnel informed about product safety during an emergency; recipients of EUI; Entities involved in the administration of countermeasures.

HHS Secretary

Official who makes declarations of emergency justifying EUAs

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

6

Expiration date extensions

Authority to extend product dating without an EUA

expiration dating

change in packaging or expiration dating

risk-benefit criteria

Minimum criteria for issuing an EUA for preparedness purposes

labeled expiration date

Seeking an extension of product shelf life; The date beyond which a product may require an extension

May be effective

The evidentiary standard for EUA issuance

Expiration Date

Property of a device that may be changed via established protocols

Identified Hazards

Hazards

4

CBRN

Chemical, biological, radiological, and nuclear agents; CBRN emergencies that would trigger an EUA.; Chemical, Biological, Radiological, and Nuclear emergencies; Chemical, biological, radiological, and nuclear agents.

CBRN emergency

Chemical, biological, radiological, or nuclear emergency

Pandemic influenza

Emerging infectious disease threat

CBRN agent

chemical, biological, radiological, or nuclear agents causing diseases; Chemical, biological, radiological, or nuclear agents causing serious diseases; Chemical, biological, radiological, and nuclear threats; exposure to chemical, biological, radiological, or nuclear agents

Related CFR Sections (4)

21CFR601.90§ 601.90 Scope.
This subpart applies to certain biological products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This suRead full regulation →
21CFR314.600§ 314.600 Scope.
This subpart applies to certain new drug products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This subpRead full regulation →
21CFR312.320§ 312.320 Treatment IND or treatment protocol.
Under this section, FDA may permit an investigational drug to be used for widespread treatment use.Read full regulation →
21CFR812.36§ 812.36 Treatment use of an investigational device.
(a) General. A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available. During the clinical trial or prior to fRead full regulation →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
2025-10-21
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
2025-10-07
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
2025-09-23
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
2025-09-16
Clinical Investigator
Shirish M. Gadgeel, M.D.
2025-09-09