The FDA has issued a revised guidance on medtech manufacturers’ obligations to notify the agency of permanent discontinuance or manufacturing interruptions.
The finalized document, issued Jan. 7, aims to mitigate potential device shortages during public health emergencies (PHE). It is part of the Federal Food, Drug, and Cosmetic Act under Section 506J that was introduced by the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020. The update supersedes the draft guidance initially released on November 13, 2023.
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“FDA plays a critical role in protecting the United States from threats, such as emerging infectious diseases, and other PHEs,” the agency said in the final guidance. “This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices.”
Under Section 506J, manufacturers must alert the FDA at least six months before a permanent discontinuance or as soon as possible when an interuption in manufacturing could lead to a disruption in the supply chain. The FDA said failure to comply with these requirements could lead to a public disclosure of noncompliance by the FDA.
Key changes in the guidance
Changes in the updated guidance include the introduction of the 506J Devices List that categorizes devices considered critical to public health during emergencies. The FDA said manufacturers of these devices are required to provide the agency with timely notifications to help prevent supply chain issues. FDA will periodically review and update the list based on public health needs.
“FDA leveraged the information and perspectives shared during the collaborative efforts to develop the CMDL, lessons learned during previous PHEs and other events that have led to shortages of critical medical devices, and all of the information described above, including the public comments and Panel recommendations, to develop the 506J Device List,” the agency said.
The guidance also expands on voluntary notifications. Manufacturers can report anticipated supply chain challenges when a public health emergency has not been declared. The agency said examples of circumstances to report include labor shortages, raw material delays, or cybersecurity vulnerabilities affecting software-enabled devices.
Throughout the final guidance, FDA emphasized the importance of early communication between manufacturers and the agency to ensure proactive steps are taken to prevent shortages. The FDA used 506J notifications throughout the COVID-19 pandemic to expedite regulatory processes and coordinate with manufacturers.
The final guidance outlines the criteria the FDA uses to determine whether a device is in shortage and how manufacturers can submit notifications. The FDA recommends using its electronic notification system of emailing the corresponding FDA office to submit notifications on-time.
