Summary: The FDA has issued final guidance defining “remanufacturing” for reusable medical devices. This guidance aims to clarify the distinction between remanufacturing and servicing, ensuring consistency and understanding of federal laws and regulations. It highlights the significant changes to device performance, safety, or intended use as key factors in remanufacturing.

Key Takeaways:

  • Clarity on Definitions: The FDA distinguishes remanufacturing as activities significantly altering a device’s performance, safety, or intended use, unlike servicing, which involves routine maintenance.
  • Guidance Issuance: The guidance was developed after extensive review and public comments, addressing the need for clarity due to differing regulatory implications.
  • Regulatory Compliance: The FDA emphasizes adherence to federal laws and quality system regulations, using specific criteria rather than self-identification to determine remanufacturing activities.

The U.S. Food and Drug Administration (FDA) has issued final guidance on the definition of “remanufacturing” for reusable devices needing maintenance or repair.

The final guidance was meant to ensure that there is consistency in what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities.

Extensive Review and Public Feedback

The final guidance was issued following the FDA’s extensive review of postmarket information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.

“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.”

FDA Definitions and Guidance on Remanufacturing

The FDA is advising in its final guidance that devices include instructions necessary for proper device servicing, as well as providing examples of activities that constitute remanufacturing.

According to its final guidance, the FDA considers remanufacturing to be the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use.

Regulatory Compliance and Examples

The agency defines servicing as the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.

The FDA determines whether the specific tasks performed on the device constitute “remanufacturing” activities according to the Federal Food, Drug, and Cosmetic Act and its implementing regulations, such as the quality system regulation, but not according to an entity’s self-identified designation as a “remanufacturer” or a “servicer.”

Simply put, remanufacturing is when a significant alteration is made to a device’s performance, safety specifications or its intended use, changing the device from what was legally marketed as approved, cleared or authorized by the FDA.

The final guidance sets forth guiding principles that the FDA recommends applying in the context of remanufacturing, including a flowchart to help determine whether activities may be remanufacturing and examples that may be helpful to industry.