The FDA has released its final guidance on remanufacturing medical devices, clarifying the distinction between device remanufacturing and servicing. This follows the draft guidance published in 2021, which aimed to address the ambiguity regarding when servicing becomes extensive enough to be considered remanufacturing.
The draft defined remanufacturing as any act performed on a finished device that significantly alters its performance, safety, or intended use, including activities such as renovating, repackaging, or restoring products. After reviewing feedback on the draft, the FDA has retained this definition but made changes to other parts of the document.
The guidance now explicitly applies to “entities that perform servicing or remanufacturing,” with a new section titled “Regulatory Requirements and Considerations for Remanufacturers.” This section provides an overview of the FDA’s medical device regulations, covering topics such as market authorization and product safety requirements, which are familiar to manufacturers but may be less known to companies that service medical devices.
Advamed, a trade group, was among those who requested the FDA to consider the needs of third-party servicers and to simplify the guidance for those not well-versed in regulatory terminology. The FDA made updates to explain that certain modifications, like changing a printed circuit board design or temporarily breaking a seal to replace a component, can significantly impact safety and performance specifications.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, noted that the clarified definitions will aid organizations in maintaining devices without altering their safety, performance, or intended use. He emphasized that the guidance removes perceived barriers to obtaining repair or maintenance services.
As reported by MedtechDive, the final guidance’s release comes two years after Congress discussed defining medical device remanufacturing in the FDA’s user fee bill, which was later extended without addressing remanufacturing through 2027.