FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .................................................................................................................................... 1

3. Responsibility............................................................................................................................2

4. Background...............................................................................................................................3

5. References/Supporting Documents............................................................................................ 4

6. Procedure ................................................................................................................................... 4

7. Glossary/Definitions.................................................................................................................... 6

8. Records ................................................................................................................................. 6

9. Document History ....................................................................................................................... 6

10. Change History ........................................................................................................................... 7

11. Attachments..............................................................................................................................7

1. Purpose

This Field Management Directive (FMD) provides criteria and instructions to

investigators when conducting an investigation requested by a Center, of a

facility engaged in the manufacturing, packaging, labeling or testing of certain

medical products that may be granted an Emergency Use Authorization (EUA).

2. Scope

This FMD applies to investigations related to issuance or potential issuance of

an EUA for medical products. These investigations can take place prior to or

after the submission of an EUA request. Investigations conducted under this

FMD will facilitate access to certain medical products that may be urgently

needed for use in declared public health or other national emergencies by

gathering information about the facility, the manufacturing processes and the

ability to maintain the quality and consistency of the subject product.

This FMD is not intended to replace or supersede any existing FDA regulatory

authority or oversight related to inspections, other types of investigations under

Chapter 8 of the Investigations Operations Manual (IOM), or other review

activities, including but not limited to: pre-operational reviews under FMD-135,

Pre-operational Reviews of Manufacturing Facilities; New Drug Application

(NDA) and Abbreviated New Drug Application (ANDA) pre-approval or Biologic
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

License Application (BLA) pre-license or pre-approval inspections for the

Center for Drug Evaluation and Research (CDER); BLA pre-license

inspections for the Center for Biologics Evaluation and Research (CBER);

Premarket Approval inspections for the Center for Devices and Radiological

Health (CDRH), or an inspection of a facility engaged in the manufacturing,

packaging, labeling, or testing of a medical product(s) that may be subject to

an EUA.

3. Responsibility

A. Center

1. Issue a written memorandum to the appropriate Office of Regulatory Affairs

(ORA) Office of Medical Products and Tobacco Operations (OMPTO)

program per established procedures requesting an investigation or, if there

are exigent circumstances, an email providing all relevant background

information and directions for the investigation.

2. Provide support to FDA investigators, as needed, during the investigation.

3. Direct any firms requesting a copy of the investigation memorandum to file

a Freedom of Information Act (FOIA) request through 

(https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm).

B. ORA Office of Medical Products and Tobacco Operations (OMPTO)

1. Assign an investigator(s) to conduct the EUA investigation as requested by

the Center.

2. Provide direction to FDA investigators, as needed, during the investigation.

3. Coordinate and confer with the Center, as necessary, to optimize the

efficiency and outcome of the investigation.

C. ORA Investigator(s)

1. Conduct the investigation in accordance with the request memorandum or

email from the Center with direction from OMPTO and the ORA Program.

2. Engage with the facility’s management during the investigation regarding

any concerns FDA has with the operational status of the facility or the

medical product(s) that may be subject to an EUA.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

3. Hold a closeout meeting with facility management to convey any significant,

unresolved concerns regarding the facility or the medical product(s) that

may be subject to an EUA.

4. Complete an investigation memorandum.

5. Direct any firms requesting a copy of the investigation memorandum to file

a FOIA request: 

(https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm).

D. ORA’s Division of Information Disclosure Policy in the Office of Strategic

Planning and Operational Policy (DIDP)

Release, the EUA investigation memorandum as appropriate, when

requested under FOIA procedures, and appropriately redacted, under FOIA

and 21 C.F.R. Chapter 1, part 20.

4. Background

Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides

authority for FDA to grant an EUA during the effective period of a declaration 

issued pursuant to section 564(b) of the FD&C Act by the Secretary of the

Department of Health and Human Services (HHS), for a medical product

intended for use in an actual or potential emergency (emergency use). An

EUA allows unapproved medical products and approved products with 

unapproved uses to be introduced into interstate commerce if they may be

effective as medical countermeasures during declared public health and other

national emergencies and there is no available, approved alternative.

FDA’s authority to issue an EUA is separate and distinct from the use of a

medical product under an investigational application (i.e., Investigational New

Drug Application (IND) or Investigational Device Exemption (IDE)), section 561

expanded access authorities, and section 564A emergency use authorities.

Interactions between a sponsor and FDA prior to or after submission of an

EUA request may include investigations by an FDA investigator(s) of a facility

that will manufacture, package, label or test a medical product subject to an

EUA, in order to gather information requested by the Center to inform their 

decision-making process on an EUA.

An investigation is an information gathering activity conducted by FDA under

Chapter 8 of the Investigations Operations Manual (IOM). The purpose of an

investigation is to determine and document facts concerning a particular issue
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

so that FDA can make informed and sound decisions1. The EUA investigation

described in this FMD allows FDA to assess the current operational status of a

facility, to provide feedback which may assist the facility in manufacturing,

packaging, labeling or testing a product intended for use in a public health

emergency, and help achieve the overall public health goal of providing

emergency use access to safe, effective, and quality novel critical therapies or

diagnostics.

EUA investigations can take place in any establishment, foreign or domestic,

that may be associated with an EUA submission, including the drug substance,

medical device, and finished dosage product manufacturing, and control

testing laboratories. Section 351 of the Public Health Service Act and sections

702 and 704 of the Federal Food, Drug and Cosmetic Act provide regulatory

authority for FDA to conduct investigations and to collect records at

establishments where medical products, including those that may be subject to

an EUA, are manufactured, packaged, labeled, or tested.

5. References/Supporting Documents

A. FDA Emergency Use Authorization website, including a list of current EUAs

with authorization information.

B. FDA Guidance for Industry and Other Stakeholders, Emergency Use

Authorization for Medical Products and Related Authorities, issued January

2017.

C. Investigations Operations Manual (IOM); Chapter 8

D. 21 CFR Chapter 1, part 20 – Public Information

6. Procedure

A. If a Center decides to request an investigation of a facility that is engaged or

may become engaged in the manufacturing, packaging, labeling or testing of a

medical product(s) that may be subject to an EUA, the Center will issue a

written memorandum to the appropriate ORA OMPTO program, per the usual

assignment procedures, to perform an investigation of that facility.

1 Subchapter 8.1 of the IOM.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

B. The Center memorandum will contain all relevant background information in

the Center’s possession, that is pertinent to an investigation of the facility and

the medical products(s) that may be subject to an EUA. Background 

information will identify, as appropriate, those areas that the Center believes

are important when considering the issuance of an EUA. When the Center

believes that an immediate investigation is necessary, it may issue an

abbreviated memorandum, or the relevant background and directions for the

investigation may be communicated through an email.

C. ORA will assign an investigator(s) to perform an investigation of the facilities

and manufacturing operations related to the medical product(s) that may be

subject to an EUA. A Center staff member(s) will be invited to join the

investigation on-site. Alternatively, a Center staff member(s) may be consulted

to provide input to the investigator(s) during the investigation.

D. An ORA subject matter expert(s) will be assigned to serve in a consultative

role in the development of the investigational plan, including liaising with

Center and ORA management if needed, and will be the point of contact for

the investigator(s) during the investigation for any on-site issues. The subject

matter expert will work in close collaboration with the investigator(s)’

supervisor(s).

E. Once assigned, the investigator(s) will contact the firm to schedule an EUA

investigation. Upon arrival at the facility, the FDA investigator(s) will show their

credentials and issue a Form FDA 482 to the most responsible individual at the

facility.2 A Form FDA 482 is not issued to foreign firms. The investigator(s) will

collect information and records regarding the firm’s operational activities

including those that are in various stages of development.

F. After initiation of the EUA investigation, OMPTO will coordinate with the 

relevant Center, as necessary, to optimize the efficiency of the investigation.

The investigator(s) should discuss FDA concerns regarding the facility, its

operations, and/or the medical product(s) that may be subject to an EUA, with

the facility’s management during the course of the investigation.

G. The investigator(s) will hold a closeout meeting with the facility, during which

they will orally convey any such concerns. In certain circumstances, with the

appropriate OMPTO program concurrence, the investigator(s) may conduct the

2 Subchapter 8.1 of the Investigations Operations Manual (IOM).
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Office of Medical Products and Tobacco Operations

(OMPTO)

Document Number:

DIR-000088

Revision #: 00

Revised:

01/25/2021

Title:

FMD-153 Investigations of Facilities engaged in the Manufacturing,

Packaging, Labeling, and Testing of Medical Products that may be subject to

an Emergency Use Authorization (EUA)

Page 1 of 7

close-out meeting with the facility remotely. During the close-out meeting, the

investigator(s) will advise the firm that they should promptly respond to any 

unresolved concerns in writing to the applicable program office according to

established procedures. At this point, if requested under a Freedom of

Information Act request, the EUA memo will be considered releasable with 

appropriate redactions of non-public information. As stated in the FDA’s

Guidance for Industry and Other Stakeholders, Emergency Use Authorization

for Medical Products and Related Authorities, issued January 2017, “FDA will

periodically review the circumstances and appropriateness of an EUA,

including circumstances that might warrant revocation of the EUA. The review

will include regular assessment based on additional information provided by 

the sponsor of the progress made with respect to the approval, licensure, or

clearance of the unapproved product, or of the unapproved use of an approved

product, for which an EUA was issued.”3

H. In accordance with Chapter 8 of the IOM, investigations will be documented in

an investigation memorandum. The investigation memorandum will be 

available to the facility subject to the inspection when DIDP determines that

the document is releasable under FOIA and has been appropriately redacted

under FOIA and 21 C.F.R. Chapter 1, part 20.

7. Glossary/Definitions

N/A

8. Records

N/A

9. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Nameand Title

3 FDA Guidance for Industry and Other Stakeholders, Emergency Use Authorization for Medical Products and Related

Authorities, issued January 2017, p. 29.
00 I 01/25/2021

Ann M. Metayer,

Regulatory Counsel, Office

of Strategic Planning and

Operational Policy, 

Division of Operational

Policy

Judy McMeekin, Pharm.D.

Associate Commissioner for

Regulatory Affairs

* - D: Draft, I: Initial, R: Revision

10. Change History

Revision

# Change

00 Initial Document

11. Attachments

N/A