The new article highlights the key points related to the requests, the way they should be submitted, as well as the relevant processes and procedures associated thereto.

HSA Guidance on Change Notification: Overview

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the process to request a review of the authority’s decision not to issue certain export certificates for medical devices.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.

Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.

Introduction to FDA Guidance for CFG and CFG-NE Requests

As described in the previous article, the present document issued by the FDA is intended to provide additional guidelines for entities seeking a Certificate to Foreign Government (CFG) or CFG for Non-Establishment (CFG-NE) for medical devices.

This guidance provides additional recommendations in the context of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for entities whose requests for a CFG or CFG-NE have been denied.

The introduction outlines the scope and intent of the document, underscoring its alignment with recent legislative amendments, such as the Consolidated Appropriations Act 2023, and the FDA Reauthorization Act 2017.

In particular, the document outlines the basics important for understanding the procedural aspects and the legal context within which the FDA operates and issues such guidance.

FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Key Concepts and Definitions

Review Process for Denied CFG or CFG-NE Requests

The guidance further explains the FDA’s commitment to addressing issues related to CFG or CFG-NE denials through the Center for Devices and Radiological Health (CDRH) Exports Team and the Center for Biologics Evaluation and Research (CBER) Import and Export Staff.

It details the two types of review processes available to entities after a denial. The first review process, under Section 801(e)(4)(E)(ii)(I) of the FD&C Act, includes a supervisory review, a meeting or teleconference opportunity, and defined timeframes, even though not strictly adhering to the specific timeframes set in section 517A(b)(2)&(3).

The second review type, under Section 801(e)(4)(E)(ii)(II), allows entities to present new information addressing the reasons for the initial denial.

Thus, recommendations contained in the document are critical in providing entities with a clear understanding of their options and the specific procedural steps following a denial.

Procedures for Requesting a Review

The document also outlines the procedures for entities to request a review of the FDA’s decision. According to the guidance, the parties responsible for medical devices are expected to provide the information required in their review request, including personal and firm details, specific denial reasons, and supporting documentation.

The review request must be submitted within a specified timeframe (60 calendar days from the denial date) and must be sent to the appropriate FDA department.

This part of the document serves as a practical guide for entities in preparing and submitting their requests, ensuring compliance with FDA requirements.

In particular, a request for review should contain the following:

  • An email subject line that states: “Request for Review of FDA’s Decision to Deny a CFG or CFG-NE” and the CFG or CFG-NE application number

  • 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.

Considerations and Timeframes for Review

The final part of the guidance describes in detail the timeframes and considerations for the review process.

It emphasizes that while the FDA will make all reasonable efforts to meet specific timeframes, the actual duration may vary based on the complexity of the issues in question and the availability of agency resources.

The document further clarifies that the guidelines provided by the FDA are recommendations and do not establish legally enforceable responsibilities.


In summary, the present guidance document provides comprehensive instructions and clarifications for entities seeking CFG or CFG-NE certifications, particularly addressing the aspects and procedural details for those whose requests have been denied.
The document provides additional clarifications on the steps to be taken by an interested entity in case its request is denied.

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