Category Archives: Reprocessed Single-Use Devices

Blogs in this category are specific to reprocessed single-use devices.

Reprocessed Single-Use Devices: Optimizing your efforts for 510(k) preparation

This article explains the challenges reprocessors face in obtaining 510(k) clearance for reprocessed single-use devices when they are not the OEM. With increasing pressures on the medical device industry to make healthcare more affordable, there has been a push to reprocess and reuse single-use devices. Reprocessors obtain used devices from healthcare facilities. The reprocessors clean, process, resterilize, repackage, and relabel

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