Does the reprocessor comply with all applicable FDA requirements?
Reprocessing in compliance with applicable FDA requirements helps to assure the safety and efficacy of reprocessed devices. It is important to inquire whether a reprocessor under consideration is adhering to all of the “non-premarket” requirements discussed above, and has submitted premarket review applications in accordance with the agency’s new regulatory scheme for reprocessing. Does the reprocessor functionally test/inspect all of its devices? Functional testing/inspection is critical to ensuring the safety and efficacy of reprocessed devices. It is important to select a third-party reprocessor that tests/inspects all of its reprocessed devices, rather than merely a sampling. Does the reprocessor track the devices it reprocesses? Tracking, or the process of monitoring a reprocessed device, enables reprocessors to collect important safety/efficacy information (e.g., the number of times a device has been reprocessed), and helps ensure that devices are not “co-mingled” (i.e., that a h
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