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We have a medical device that is reusable but is limited to the number of total uses by electronic means. We have found out that a third party is "re-programming" our used product as selling it as refurbished. Besides the financial implications there is also a concern that we have verified and validated our device for a reasonable number of uses which support the labeled maximum number of uses. I cannot find anything on the web about any FDA requirements for third party refurbishers which is scary to me not only as a manufacturer but also as a consumer/patient. Is it true that just about anyone today can pick up a used medical device or piece of equipment, clean it up and resell it as refurbished? How can a third party ensure that the device meets the original manufacturer's specifications and test requirements? Scary indeed. Comments?