The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory decisions.
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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 be followed when requesting 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 the parties involved to ensure compliance thereto.
At the same time, it is important to notice that 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 legal framework and has been agreed with the authority in advance.
In particular, the FDA has updated its guidance document, originally issued in compliance with the FDA Reauthorization Act 2017, to align with the Consolidated Appropriations Act 2023.
This guidance primarily deals with the processes and criteria related to the issuance and denial of Certificates to Foreign Government (CFG) and Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) for medical devices.
Scope of the Guidance
The guidance applies to entities that face denial of CFGs or CFG-NEs under specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
It outlines the process and information provision by 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).
These certificates are relevant for devices manufactured in establishments registered under section 510 of the FD&C Act, including FDA-approved, cleared, or exempted devices. The guidance applies to devices both exported from and not exported from the United States.
Denial of CFG or CFG-NE
The FDA may deny CFG or CFG-NE requests for several reasons, such as if there is an ongoing injunction proceeding, a seizure action, the device is subject to a Class I or Class II recall, or if the manufacturing establishment is not compliant with the applicable Quality System regulation. Additionally, for CFG-NE, denial may occur if certain conditions specified in the FD&C Act are not met, such as the device not being imported or offered for import into the United States.
In case of denial, the FDA will inform the requestor via email, specifying the basis for denial and identifying the specific findings that led to this decision.
If the denial is due to non-compliance with Good Manufacturing Practices (reason 4), FDA will provide a detailed summary of the specific grounds for noncompliance.
However, the FDA does not intend to deny CFGs or CFG-NEs for establishments classified as No Action Indicated (NAI) or Voluntary Action Indicated (VAI) based on the most recent quality system inspection.
If a CFG or CFG-NE request is denied due to non-compliance of a related establishment, the FDA will send the denial email to the requestor, but the substantive summary will be sent to the non-compliant establishment. In cases of open recalls, FDA’s decision to issue a certificate will be based on the current status of the recalled products.
Plan of Correction
Upon receipt of the substantive summary for noncompliance, the parties responsible for the medical devices in question can submit a plan of correction.
The FDA will not deny a CFG or CFG-NE request solely because the device was manufactured in an establishment that received an FDA Inspectional Observations form (Form FDA 483) if a plan of correction is agreed upon.
This plan should include steps to address and prevent the recurrence of the inspection observations, along with timeframes for completion and documentation of corrective/preventive actions.
The plan of correction should be submitted via email, clearly stating “Plan of Correction” along with the establishment name and FDA Establishment Identifier number.
The FDA will review the plan and notify the establishment about its sufficiency. The response time from the FDA generally depends on various factors such as the Agency’s resources, the complexity of the noncompliance issues, and the responsiveness of the establishment, to respond within 90 days.
If the plan is deemed sufficient, and a CFG or CFG-NE application is under review or subsequently submitted, FDA will issue the certificate unless other grounds for denial exist. Should there be a need to modify the plan of correction, the establishment must inform the FDA.
In summary, the present guidance document issued by the FDA outlines the specific conditions under which the authority may deny CFGs or CFG-NEs, the process of notification, and the steps establishments can take to rectify issues leading to denial. By providing a structured approach for dealing with denials and corrective actions, the FDA intends to ensure that medical devices manufactured in compliance with its regulations can be appropriately certified for foreign markets, whether they are exported or not.
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