FDA Issues Draft on Remanufacturing of Medical Devices

The United States Food and Drug Administration (FDA) has deployed draft guidance entailing the agency’s views and opinions of what embodies a remanufactured medical device and to aid clarification of regulatory requirements associated with such devices.

The draft guidance titled “Remanufacturing and Servicing Medical Devices” explains Remanufacturing to be a systematic procedure consisting of the processing, conditioning, renovating, repackaging devices, restoring or any other modification act applied to a finished medical device that significantly changes the attributes and characteristics of the finished device including a novel approach towards enhancing the performance and utility along with safety specifications associated with the Remanufacturing process.

Servicing established in the draft guidance, on the other hand, is defines as the procedure following repair and preventative or routine maintenance activities of one or more parts of a particular finished device with the objective of returning the device to safety, and performance specifications deployed by the original equipment manufacturer (OEM), and finally, satisfy the device’s original intended use. The Food and Drug Administration highlights the distinction of Remanufacturing and servicing regulations to be important in determining the exact regulations applied in assessing the safety and performance of Remanufacturing medical devices.

The draft guidance explains that the FDA imposes a requirement under the established FD&C Act coupled with the implementation of regulations on various entities engaged in Remanufacturing and remodifying devices, comprising however not restricted to the registration, and listing along with adverse event reporting, the Quality System (QS) regulations, and Marketing submission.