Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification

Lexology June 21, 2024
Hall Render Killian Heath & Lyman PC

In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device repairs and modifications performed on devices “are likely manufacturing,” as well as to “provide consistency and better understanding of applicable statutory and regulatory requirements.”

The Final Guidance represents the culmination of the FDA’s longstanding efforts to provide more guidance on what constitutes remanufacturing versus servicing. In 2018, the agency issued a report in response to a request from Congress in the Food and Drug Administration Reauthorization...

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