The US medical device circulation regulating authority, the Food and Drugs Administration (FDA), has issued guidance describing the issues related to denial in handling an export certificate.

The Scope of the Guidance: Export Certificates


The guidance is dedicated to issues concerning denial when providing a Certificate to Foreign Government (CFG) for a medical device. A CFG is a certificate issued to a manufacturer regarding any device produced in compliance with the section 510 of the Food, Drugs and Cosmetics (FD&C) Act. This document highlights the necessary information that must be provided by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) in the case of a refusal in issuing a CFG.

The CDRH is a special body of the FDA responsible for ensuring the safety and effectiveness of medical devices. They are also responsible for making important information on medical devices available to all parties including patients, healthcare professionals and medical device manufacturers. The CDRH also supervises the  circulation of radiation-emitting products. The CBER is a special body of the FDA authorized to regulate the circulation and ensure the safety and effectiveness of biological products intended for human use. All topics concerning export certificates for medical devices manufactured in the US are regulated by section 801 of the FD&C Act. 

Denials in Issuing Export Certificates for Medical Devices


Applicable regulations provide a list of possible reasons a manufacturer could receive a denial in handling a CFG. Some possible reasons are as follows:

  1. A seizure action;
  2. An injunction proceeding;
  3. The manufacturer fails to comply with the Quality System regulations;
  4. The FDA designates a recall regarding medical device.


Quality System regulations, or the Current Good Manufacturing Practices (CGMP) is a set of requirements that apply to the medical products subject to FDA regulations. Since the scope of QS application is very wide and includes various types of medical devices, the regulations are pretty flexible considering the general requirements and the establishment of a regulatory umbrella framework. According to the QS, medical device manufacturers should begin to implement and employ the necessary manufacturing practices and procedures. These can be determined depending on the particular medical device. The QS principles can be applied at any step of the process including design, manufacturing and distributing medical devices to ensure safety and effectiveness. In fact, QS provides a list of important elements to be included into the quality management system implemented by the manufacturer.

In the case of denial due to any valid reason, the FDA is obligated to provide medical device manufacturers with detailed information regarding the particular reasons for denial, including specific references to the QS. The regulating authority would provide the explanation for all noncompliance issues. This guidance emphasizes that the FDA would not refuse to issue a CFG for QS compliance issues if the quality system inspection confirms that none of the actions taken by the manufacturers are voluntary. It is also important to mention that information on the CFG handling denial would be provided exclusively to the entity found noncompliant even if it has been requested by a third party company. Meanwhile, the third party company would receive information on the reasons for denial in relation to their company. 

If a medical device manufacturer requests a CFG for a medical device subject to recall, the decision of the FDA would be based on the current status of the device. In this case, the manufacturer must make sufficient changes to the device (rework it) to create grounds to review the recall. The FDA must evaluate the information on the changes made and perform examinations necessary to assess the compliance of the reworked device with the applicable regulations. However, if the recall decision covers only certain devices (lot-specific recall), the CFG could be issued for other lots falling outside the scope of the recall. In this situation, the manufacturing should sign an appropriate statement confirming that lots subject to recall would not be shipped. 


Correction Plan


To restore compliance standards, the manufacturer must develop an appropriate plan describing measures to be taken and it must be approved by the FDA. The manufacturer could develop a plan of correction as a reaction on the FDA Inspectional Observations – a special document that describes noncompliance issues. In that case, the following steps should be taken: 

  1. The manufacturer should submit a detailed plan of correction containing the description of measures to be taken to eliminate the noncompliance issues highlighted it the Inspectional Observations to the FDA. This should also include the terms and the actions planned to be taken. The submission should also include the FDA Establishment Identifier (FEI) number. 
  2. Within 90 days (the exact time period may vary depending on the complexity of the particular case) the FDA would provide the manufacturer with the response on the sufficiency of the measures and actions described in the plan of correction. At the same time, the FDA may request additional information, clarification or explanations if found necessary when reviewing the plan. 
  3. If the FDA finds the changes to be implemented sufficient to restore compliance, the authority would issue the CFG requested by the manufacturer as long as there are no any other grounds for refusal. 


It is important to mention that the manufacturer must notify the FDA on any changes made to the plan of correction during the implementation process. 


CFG Request Denial Review


According to the applicable regulations, denial to provide a CFG could be reviewed upon the request of the manufacturer. Current legislation provides two types of review procedures: 

  1. Review in accordance with Section 801 of the FD&C Act:

The request to review the decision should be submitted within 60 days from the date of receiving the decision. The request should contain: 

  • the number of the initial CFG application;
  • the information on the applicant, including the company name, address and contact details; 
  • the information on the particular company associated with the CFG denial, including the FEI number;
  • a reference to the inspection observations; and 
  • the detailed explanations of the reasons the application for the CFG should not be denied referencing to the materials provided with the initial application. 

The review process could also include the interviews or conferences with the representatives of the applicant if necessary. The FDA also states that the review process may exceed 30 days. 

   2. New information review in accordance with Section 801 of the FD&C Act:

An applicant has a right to request for review of the denial based on the corrective actions taken to restore compliance with the applicable regulations. In this case, the request should include the information on such actions taken or to be taken to eliminate the noncompliance issues described by the FDA. 

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