Understanding the Latest FDA Guidance on Servicing vs. Remanufacturing of Medical Devices

The U.S. Food and Drug Administration (FDA) has recently updated its guidance to clarify the critical distinctions between servicing and remanufacturing of medical devices. This guidance is essential for manufacturers, service providers, and regulatory bodies to ensure that medical devices continue to operate safely and effectively throughout their lifecycle. In this article, we define key terms and highlight how the latest FDA guidance may impact manufacturers and service providers. 

Defining remanufacturing vs. servicing

Remanufacturing is defined as processing, conditioning, renovating, repackaging, restoring, or performing any other act on a finished device that significantly changes the device's performance, safety specifications, or intended use. This comprehensive definition helps stakeholders understand what constitutes remanufacturing and the implications it has on regulatory compliance.

Servicing, on the other hand, refers to the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, to return it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use. Servicing is intended to maintain the device's functionality and safety as per OEM standards without altering its intended use.

Regulatory implications

The updated FDA guidance aims to provide consistency and a better understanding of the applicable statutory and regulatory requirements. By clarifying these terms, the FDA helps ensure that all parties involved in the lifecycle of a medical device are clear about their responsibilities and the standards they need to meet.

The distinction between servicing and remanufacturing is crucial because it determines the regulatory pathway that entities must follow. Remanufacturing activities may require additional regulatory oversight, including compliance with quality systems, premarket notification requirements, and possibly new device approvals. In contrast, servicing activities generally do not change the regulatory status of a device but must still comply with safety and performance standards.

Impact on industry practices

This updated guidance is expected to impact how manufacturers and service providers operate, necessitating a review of current practices to ensure they are in line with the new definitions and requirements. It encourages a proactive approach to compliance and enhances the overall safety and effectiveness of medical devices in the market.

By adhering to this guidance, stakeholders in the medical device industry can better navigate the complexities of device maintenance and modification, ensuring that devices remain safe and effective for users while complying with regulatory standards.

Staying ahead of compliance can be complex and manufacturers and service providers must have the right technology and processes in place. We can guide your business transformation towards high-performance operations with greater agility and speed. Contact us today to find out how we can help you stay ahead of the curve.

For more information:  https://www.fda.gov/media/150141/download