“Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices” outlined in this document navigates the regulatory landscape established by the FDA Reauthorization Act of 2017 (FDARA), particularly Section 704, and the amended Section 801(e)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Focused on the issuance of Certificates to Foreign Governments (CFG) for medical devices, the guidance outlines the procedures for individuals encountering denials to respond with corrections or request a review of the denial. Further insight into the grounds for denial, the information included in the denial, and the avenues for responding to the denial are provided within the guidance. Essential to the export process, CFGs signify that domestically manufactured medical devices comply with the FD&C Act. The guidance extends its scope to instances where CFGs are denied for medical devices falling within the field of section 510 of the FD&C Act and possessing FDA approval, clearance, or exemption. Recent legislative changes emphasize that CFGs are exclusive to devices intended for export, with manufacturers having the option to apply for a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) in other cases.
Grounds for Denial
The FDA guidance notes four reasons a request for a CFG or CFG-NE may be denied:
i. There is an injunction proceeding pursuant to section 304 of the FD&C Act; or
ii. There is a seizure action pursuant to section 304 of the FD&C Act; or
iii. The device is the subject of recall designated by FDA as Class I or Class II (in accordance with 21 CFR part 7); or
iv. An establishment is out of compliance with FDA’s Quality System regulation (also known as current Good Manufacturing Practices (cGMPs)) under 21 CFR part 820.
The FDA may also deny a request if any conditions in section 801(e)(4)(F)(i) of the FD&C Act are not met. Once denied, the requestor will be notified via an email which will include the basis for denial and the finding that the denial is based on. In the case of reason iv. seen above, the email will include a summary of noncompliance issues which will not pertain to an establishment with a No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classification. It is important to note that if denial of a CFG or CFG-NE is due to a third-party establishment, the summary will be sent to them instead of the requestor due to disclosure requirements. In the case of open recalls, FDA will base its decision on the current state of the recalled product after a review of documentation of the correction and final testing. If it is instead a lot-specific recall, a CFG or CFG-NE may still be requested if those detailed lots are not to be shipped.
Plan of Correction
When a company receives a notice from the FDA detailing reasons for denial of their request, they have an opportunity to respond by submitting a plan of corrections. In response to FDA Inspectional Observations under 704(b) of the FD&C Act, this plan should outline specific actions to be taken to rectify noncompliance. The following steps should be taken in order for FDA and the owner, operator, or agent to agree on a plan of correction:
i. The firm should submit a plan that includes the steps to be taken in preventing recurrence as well as corrective/preventative action that have been and/or will be taken. The timeline for these actions should also be included. This plan should be submitted to the FDA contact identified by the investigator with “Plan of Correction” with the establishment name and FDA Establishment Identifier (FEI) number in the subject line.
ii. A response is generally delivered within 90 days, informing the establishment of the plan’s sufficiency. The Agency may initiate further communication if needed to make a final decision.
iii. If the plan is sufficient, and a CFG or CFG-NE application is currently under review, a CFG or CFG-NE will be issued if there are no other grounds for denial.
CFG Request Denial Review
Review Under Section 801(e)(4)(E)(ii)(I)
The first review type, outlined in FD&C Act Section 801(e)(4)(E)(ii)(I) and 801(e)(4)(F)(iv), offers a supervisory review with the option for a meeting or teleconference and timeframes. FDA notes that the resolution of the review may take 30 days or more. Requests for review need to be submitted within 60 days of the denial for requesting a CFG. This request should be sent to firstname.lastname@example.org, or the CBER ombudsman using email@example.com. Information in the email should include:
- Email line stating, “Request for Review of FDA’s Decision to Deny a CFG or CFG-NE” and the application number
- The name, title firm, address, phone number and email address of individual placing the request
- The name, address, and FEI number of the establishment
- A detailed reference to the inspectional observation noted in the denial summary
- Clear reasoning as to why the request should not have been denied, including previously submitted documentation
Review of New Information Pursuant to Section 801(e)(4)(E)(ii)(II)
The second type of review allows an organization to present new information regarding actions taken to address the reasons for denial, including evidence of corrective measures being implemented to address noncompliance that has been identified by FDA in sections 801(e)(4)(E)(ii)(II) and/or 801(e)(4)(F)(iv). This review can be requested by contacting CDRH’s Exports Team at firstname.lastname@example.org or CBER Import and Export Staff at CBERBECATS@fda.hhs.gov. FDA intends to provide a response within 90 days. The information included in a request for review email is the same as above except the subject line should state “New Information – Denial of a CFG or CFG-NE” and the CFG or CFG-NE application number.
FDA’s recent guidance on Medical Device Export Certificates is a resource for establishments encountering problems in procuring a CFG or CFG-NE. Understanding this guidance provides a framework for those applying for a CFG, forming a plan of correction, or if they believe they have been wrongfully denied.
Need further guidance on how to acquire or request review for a CFG or CFG-NE? Contact MEDIcept for help at email@example.com.
Center for Devices and Radiological Health. (2023, November). Requesting Review of FDA’s decision not to issue certain export certs. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices?utm_medium=email&utm_source=govdelivery
CJ STUKEL – ASSOCIATE MEDICAL DEVICE CONSULTANT