Contains Nonbinding Recommendations
Process to Request a Review of FDA's 
Decision Not to Issue Certain Export 
Certificates for Devices
Guidance for Industry and
Food and Drug Administration Staff
Document issued on November 3, 2023.
Document originally issued on November 14, 2019. 
This document supersedes Process to Request a Review of FDA's Decision Not 
to Issue Certain Export Certificates for Devices, issued November 2020. 
For questions about this document regarding CDRH-regulated devices, contact the Exports Team 
within ORP: Office of Regulatory Programs/DRP2: Division of Establishment Support at 
exportcert@cdrh.fda.govor 301-796-7400, option 3. 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 800-835-4709 or 240-402-8010, or by 
email at ocod@fda.hhs.gov. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2018-D-2310. Comments may not be 
acted upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number GUI00017044 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov, or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ............................................................................................................................. 1
II.  Scope ....................................................................................................................................... 2
III.  Denial of a Request to Issue a CFG or CFG-NE .................................................................... 2
A.  Grounds for Denial ........................................................................................................... 2
B.  Plan of Correction ............................................................................................................ 4
IV.  Review of FDA Denial of a CFG or CFG-NE Request .......................................................... 5
A.  Review Pursuant to Section 801(e)(4)(E)(ii)(I) ............................................................... 5
B.  Review of New Information Pursuant to Section 801(e)(4)(E)(ii)(II) ............................. 6 Contains Nonbinding Recommendations
Process to Request a Review of FDA's 
Decision Not to Issue Certain Export 
Certificates for Devices
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction1 
FDA is reissuing this guidance document to make minor updates to align with section 3304 of 
the Consolidated Appropriations Act, 2023, Pub. L. No. 117-32.2 The original version of this 
guidance was issued to comply with section 704 of the FDA Reauthorization Act of 2017 
(FDARA) (Public Law 115-52), which amended section 801(e)(4) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) to specify the process afforded to persons denied a Certificate to 
Foreign Government (CFG) for a device.
This guidance describes the information that the Center for Devices and Radiological Health 
(CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with 
the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG or 
CFG-NE for a device is denied, and the process for seeking review of such a denial. 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
1This guidance has been prepared by the Center for Devices and Radiological Health and the Center for Biologics 
Evaluation and Research in consultation with Office of Regulatory Affairs.
2 Section 3304 of the Consolidated Appropriations Act, 2023 directs FDA to provide certification for devices that 
are not exported from the United States if certain conditions are met. Section 3304 strikes clause iii of section 
801(e)(4)(E) of the FD&C Act and adds subparagraph (F), to provide that the requirements and procedures of 
subparagraph (E) apply to a denial of a certification under subparagraph (F) for a device not exported from the 
United States.
1 Contains Nonbinding Recommendations
the word should in Agency guidances means that something is suggested or recommended, but 
not required.
II. Scope 
This guidance applies to the process for persons denied CFGs requested pursuant to section 
801(e)(4)(A)(ii) of the FD&C Act or denied CFG-NEs requested pursuant to section 801(e)(4)(F) 
of the FD&C Act for devices manufactured in an establishment registered under section 510 of 
the FD&C Act (e.g., FDA-approved, cleared, or exempted devices). Specifically, this guidance 
describes the information that CDRH and CBER, in collaboration with ORA, will provide to a 
person whose request for a CFG or CFG-NE is denied, and the process for seeking review of 
such a denial.3
Section 801(e)(4)(A)(ii) of the FD&C Act applies to export certificates for devices, as well as 
other FDA-regulated products, that are exported from the United States. Such FDA export 
certifications provide information concerning a product and/or establishments regulatory or 
marketing status, based on available information at the time FDA issues the certification 
(including, as appropriate, attestations provided by the person seeking the export certification).  
Upon issuance, FDA certifies in writing that the exported product meets applicable requirements 
of the FD&C Act.4 Revisions to section 801(e)(4) of the FD&C Act as part of the Consolidated 
Appropriations Act, 2023, direct FDA to provide certification for devices that are not exported 
from the United States. Manufacturers of devices not exported from the United States, as 
described in section 801(e)(4)(F) of the FD&C Act, may not request CFGs pursuant to section 
801(e)(4)(A)(ii) of the FD&C Act, but may request a Certificate to Foreign Government for 
Device Not Exported from the United States (CFG-NE).5 Although CFG-NEs apply to devices 
not exported from the United States, the processes referenced below also apply to CFG-NEs, 
pursuant to section 801(e)(4)(F)(iv) of the FD&C Act, unless otherwise specified.
III. Denial of a Request to Issue a CFG or CFGNE 
A.  Grounds for Denial 
Among the reasons FDA may deny a request for issuance of a CFG or CFG-NE are those 
referenced in section 801(e)(4)(E)(i)(II) of the FD&C Act: 
1. There is an injunction proceeding pursuant to section 302 of the FD&C Act; or 
2. There is a seizure action pursuant to section 304 of the FD&C Act; or 
3. The device is the subject of a recall designated by FDA as Class I or Class II (in accordance 
with 21 CFR part 7); or 
3For additional information regarding FDA export certificates, see the FDA guidance entitled FDA Export 
Certification at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-
certification
4Section 801(e)(4)(A)(ii) of the FD&C Act. 
5See https://www.fda.gov/medical-devices/exporting-medical-devices/devices-not-exported-united-statesfor 
information about FDAs CFG-NE process.
2 Contains Nonbinding Recommendations
4. An establishment is out of compliance6 with FDAs Quality System regulation (also known 
as current Good Manufacturing Practices (cGMPs)) under 21 CFR part 820. 
In addition to the above reasons, FDA may deny a request for issuance of a CFG-NE if any of 
the conditions specified in section 801(e)(4)(F)(i) of the FD&C Act are not met, such as the 
device is not imported or offered for import into the United States.
If FDA denies a request for a CFG or CFG-NE for these or other reasons, FDA will notify the 
requestor via email, identify the basis for denying the request, and specifically identify the 
finding upon which such denial is based.7 For denials based on a facility being out of compliance 
with cGMPs (reason 4, above), and not on the basis of an injunction, seizure, or recall, FDA will 
include a substantive summary of the specific grounds for noncompliance with the email.8
Within the summary, FDA will describe the major noncompliance issues that are the basis for the 
denial and associated reference to the Quality System regulation. The level of detail will vary 
based on the specific facts of each individual case. FDA does not intend to deny a CFG or CFG-
NE for an establishment with a No Action Indicated (NAI) or Voluntary Action Indicated (VAI) 
classification for the most recent quality system inspection.
There may be instances where a CFG or CFG-NE is requested by a party that has a business 
relationship with an establishment that has a different owner/operator number. If the CFG or 
CFG-NE is denied because such establishment is found to be out of compliance, the CFG or 
CFG-NE requestor will receive a denial email indicating that the denial is based on matters 
pertaining to that establishment. However, pursuant to applicable disclosure requirements,9 the 
substantive summary will not be emailed to the CFG or CFG-NE requestor, but to the out-of-
compliance establishment via the owner, operator, or agent in charge of the establishment, if the 
CFG or CFG-NE requestor agrees that its pending CFG or CFG-NE request can be made known 
to the other establishment. 
For open recalls, the Agency intends to base its decision to issue a CFG or CFG-NE on the 
current status of the recalled products. For example, if a party requests a CFG or CFG-NE for a 
recalled product that has been corrected, FDA will review documentation of the correction and 
final testing of the product, per the current recall review process, to determine whether a CFG or 
CFG-NE should be issued. 
For a product line with an open lot-specific recall, lots not under recall may be included on a 
CFG or CFG-NE provided the firm signs a statement indicating that it will not ship the lots of the 
product that are subject to the recall.
6For the purposes of this guidance, out of compliance is synonymous with noncompliance. Out of 
compliance means having one or more major deficiencies with the Quality System regulation, per Compliance 
Program Guidance Manual 7382.845 Part V, available at https://www.fda.gov/media/80195/download.
7See section 801(e)(4)(E)(i)(I) of the FD&C Act. 
8See section 801(e)(4)(E)(i)(II) of the FD&C Act. 
9Trade secrets and confidential commercial information (CCI) are protected from public disclosure by the Trade 
Secrets Act (18 USC 1905), Exemption 4 of the Freedom of Information Act (5 USC 552(b)(4)), and FDAs 
disclosure regulations (21 CFR 20.61). 
3 Contains Nonbinding Recommendations
B. Plan of Correction 
The firm may submit a plan of correction after it has received the substantive summary of the 
specific grounds for noncompliance (reason 4, described above). Section 801(e)(4)(E)(i)(III) and 
section 801(e)(4)(F)(iv) of the FD&C Act provide that FDA shall not deny a request for a CFG 
or CFG-NE based solely on the grounds that the device at issue was manufactured in an 
establishment that has received an FDA Inspectional Observations form (Form FDA 483), issued 
under section 704(b) of the FD&C Act, if FDA and the owner, operator, or agent in charge of 
such establishment have agreed to a plan of correction in response to the report. For purposes of 
this guidance, FDA interprets plan of correction to mean a response to an FDA Inspectional 
Observations, issued under section 704(b) of the FD&C Act. 
For FDA and the owner, operator, or agent in charge of the establishment to agree on a plan of 
correction in response to the inspectional observations, for CFG or CFG-NE consideration, the 
following steps should occur: 
1. The owner, operator, or agent in charge of the establishment should submit, via email, a plan 
that includes steps the owner, operator, or agent in charge of the establishment is taking to 
address, and prevent the recurrence of, the inspectional observations, and timeframes for 
completing such actions. This plan of correction should also include documentation 
demonstrating the corrective/preventative actions that have been taken and/or will be taken.  
 
  To submit a plan of correction, the owner, operator, or agent in charge of the 
establishment should email the FDA contact identified by the investigator at the end of 
the inspection for submission of a response to the Form FDA 483. 
 The email subject line should clearly state Plan of Correction, along with the 
establishment name and FDA Establishment Identifier (FEI) number. 
2.   FDA will review the plan and notify the owner, operator, or agent in charge of the 
establishment via email whether the plan is sufficient to address the violations documented in 
the inspectional observations. If the Agency finds that clarification on the submitted plan of 
correction is needed, the Agency may, at its discretion, initiate further communication with 
the owner, operator, or agent in charge of the establishment prior to making a decision. 
Generally, depending upon the Agencys resources, the complexity of the noncompliance 
issues presented, and the responsiveness of the owner, operator, or agent in charge of the 
establishment, FDA intends to provide a response to a plan of correction within 90 days. 
3.   If the plan is determined to be sufficient, and a CFG or CFG-NE application is currently 
under review10 or subsequently submitted to the Agency, FDA will issue a CFG or CFG-NE, 
if no other grounds for denial are present. 
10The FD&C Act limits the processing of a CFG request to within 20 working days of receipt of the request (section 
801(e)(4)(A)(ii) of the FD&C Act. As such, it may be necessary for the establishment to submit a new CFG 
application. As indicated in the Guidance FDA Export Certification (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/fda-export-certification), FDA has interpreted the 20-day period to 
mean 20 government working days. 
4 Contains Nonbinding Recommendations
If an establishment is implementing a plan of correction and determines that modifications to the 
plan are necessary, it should notify FDA of the modifications via the previously identified 
contact information.
IV. Review of FDA Denial of a CFG or CFGNE Request 
The CDRH Exports Team and the CBER Import and Export Staff will make every effort to 
directly resolve issues. In addition, the statute provides that persons denied a CFG or CFG-NE 
may request review of the Agencys decision, and outlines two distinct types of review. The 
process for requesting such reviews is outlined below.
A. Review Pursuant to Section 801(e)(4)(E)(ii)(I) 
Section 801(e)(4)(E)(ii)(I) and section 801(e)(4)(F)(iv) of the FD&C Act direct FDA to provide 
a process for a person who is denied a CFG or CFG-NE for a device to request a review that 
conforms to the standards of section 517A(b) of the FD&C Act. CDRHs review process11
follows the standards of section 517A by providing for supervisory review, opportunity for a 
meeting or teleconference, and timeframes, except it does not adopt the specific timeframes set 
forth in section 517A(b)(2)&(3). FDA will strive to meet the timeframes outlined in 517A(b)(3); 
however, efforts to resolve any issues raised by a person whose request for a CFG or CFG-NE is 
denied may take up to, or more than, 30 days to be completed. In addition, since the denial of a 
request to issue a CFG or CFG-NE is not a significant decision as defined in section 
517A(a)(1), CDRHs review process will not include the 30-day timeframe for submitting a 
request for review. Similarly, CBER will use the Formal Dispute Resolution process12 for 
submitting a request for review, but the efforts by the CBER Import and Export Staff to resolve 
any issues raised by a person whose request for a CFG or CFG-NE is denied may take up to, or 
more than, 30 days to be completed. 
The request for a review of FDAs decision not to issue a CFG or CFG-NE should be submitted 
no later than 60 calendar days from the denial date by emailing the Exports Team within 
CDRHs Office of Regulatory Programs (ORP), Division of Establishment Support using 
exportcert@cdrh.fda.gov, or the CBER ombudsman using cberombudsman@fda.hhs.gov. 
A request for review of a CFG or CFG-NE denial should include the following:
 An email subject line that states: Request for Review of FDAs Decision to Deny a CFG 
or CFG-NE and the CFG or CFG-NE application number;
11 For additional information regarding appeal review processes in CDRH, specifically appeals of actions that are 
not significant decisions, please see the guidance Center for Devices and Radiological Health (CDRH) Appeals 
Processes, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-
devices-and-radiological-health-cdrh-appeals-processes
12For additional information regarding appeal review processes in CBER, please see the guidance, Formal Dispute 
Resolution: Sponsor Appeals Above the Division Level, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/formal-dispute-resolution-sponsor-appeals-above-division-level-
guidance-industry-and-review-staff
5 Contains Nonbinding Recommendations
 The name, title, firm, address, phone number, and email address of the person submitting 
the request; 
 The name, address, and FEI number of the establishment for which the CFG or CFG-NE 
was denied;
 A clear reference to the inspectional observation(s) as noted in the substantive summary 
of the denial; and
 Information demonstrating why the request for CFG or CFG- NE should not have been 
denied, referencing previously submitted documentation.
This review process consists of a supervisory review, including an in-person meeting or 
teleconference, if requested.
B. Review of New Information Pursuant to Section 
801(e)(4)(E)(ii)(II) 
A person who has been denied a CFG or CFG-NE may at any time request a review in order to 
present new information relating to actions taken by such person to address the reasons identified 
by [FDA] for the denial of [the CFG or CFG-NE], including evidence that corrective actions are 
being or have been implemented to address grounds for noncompliance identified by [FDA] 
(section 801(e)(4)(E)(ii)(II) and section 801(e)(4)(F)(iv) of the FD&C Act. 
The owner, operator, or agent in charge of the establishment can request such a review by 
contacting CDRHs Exports Team at exportcert@cdrh.fda.gov or CBER Import and Export Staff 
within the Office of Compliance and Biologics Quality (OCBQ), Division of Case Management 
(DCM) at CBERBECATS@fda.hhs.gov. A person requesting a review of new information 
should reference, but need not re-submit, inspection related documentation previously submitted 
to FDA. 
A request for review of new information pertaining to a CFG or CFG-NE denial should include 
the same information as listed above in section IV.A., except the email subject line should state: 
New Information  Denial of a CFG or CFG-NE and the CFG or CFG-NE application number. 
CBER and CDRH will review the new information in collaboration with ORA and intend to 
provide a response within 90 days, depending upon the Agencys resources, the complexity of 
the noncompliance issues presented, and the responsiveness of the establishment.
6