Dive Brief:

• The FDA has released draft guidance for companies that are denied a Certificate to Foreign Government.

• CFGs open up markets in Asia, the Middle East and Latin America by showing a device is cleared or approved for sale in the U.S.

• However, in some cases the FDA will deny a request for a CFG. The draft guidance explains why the FDA denies requests and what options are open to companies that receive rebuttals.

Dive Insight:

A CFG is a valuable document for a medical device company with plans to enter global markets. Once a manufacturer has the paperwork, markets around the world start to open up as it gives regulators the reassurance that the FDA has signed off on a device. However, despite the importance of CFGs, there has been a lack of clarity around aspects of the process for obtaining them.

Legislators recognized that lack of clarity when drafting the FDA Reauthorization Act of 2017, leading them to stipulate that the agency must specify the process for companies denied a CFG. The draft guidance is the FDA’s response to that stipulation.

The guidance details the reasons the FDA many deny a request for a CFG. The reasons all relate to significant problems with a medical device. If a device is subject to a Class I or II recall or the facility where it is made or is not compliant with good manufacturing practices (GMP), the FDA may refuse to issue a CFG. The FDA cannot reject applications if a plant has only received a Form 483, a warning after an agency inspection of potential violations.

Companies that are rejected will receive a notice specifying why their request was turned down. If the denial relates to GMPs, the FDA will “provide a substantive summary” explaining the grounds for noncompliance identified by its inspectors.

The law permits companies to request a review at any time to present evidence of corrective actions and other information related to the noncompliance. The guidance provides details of how a company can make this request. Typically, the Center for Devices and Radiological Health exports branch and its import and export staff will directly resolve issues. However, a review process exists for when a resolution can not be agreed to.

The FDA published the draft guidance alongside other medical device documents, including its final position on a streamlined mechanism for reporting malfunctions.