The FDA has issued the final guidance: Remanufacturing of Medical Devices as part of its ongoing efforts to help distinguish between remanufacturing and servicing. This guidance clarifies whether activities performed on devices are likely “remanufacturing,” which differs from servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers.
The guidance defines remanufacturing as a service that causes significant changes to a device’s intended use (e.g., changing a single-use device to become reusable or changing the anatomical location of use) and offers a flow chart for activities involving components/parts/materials to help entities determine if their activities are likely remanufacturing.
The FDA notes that while the servicing and remanufacturing definitions and guiding principles provided in the document apply to software, the approach to determining whether activities are “remanufacturing” may differ between software and other components of medical devices Thus, the guidance includes specific methods of determination unique to device software and SaMD.
The guidance also recommends that OEMs include following information in the labeling of reusable medical devices to help ensure the device is returned to the performance and safety specifications established by the OEM during servicing:
- A description of the key performance and safety specifications;
- Critical technical or functional specifications, including physical dimensions, electrical characteristics, and device-specific performance specifications
- The recommended maintenance activities and schedule
- Recommended troubleshooting steps, routine testing, and acceptance criteria to confirm that the device remains within its performance and safety specifications
- A description of error codes, alerts, and alarm features on the device
- Precautions, and warnings relevant to servicing the device
- Version number and release date of software
On June 27 from 1:00pm-2:00pm ET the FDA will host a webinar for those interested in learning more about the final guidance.
Download the final guidance here.
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