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Good Refurbishment Practices

In 1996 the FDA removed the terms “refurbisher” and “servicer” from current good manufacturing practices definition of a manufacturer. (See Federal Register: October 7, 1996 volume 61, number 195)

Refurbished: For the purpose of resale or redistribution, visually inspected, functionally tested and serviced, as may be required, to demonstrate that the device is in good repair and performing all the functions for which it is designed.  The device may or may not be cosmetically enhanced.  Preventive maintenance procedures may or many not be performed.  Refurbishers do not significantly change a finished device’s performance or safety specifications, or intended use. (Federal Register, volume 62, number 246)

Reconditioned: When a person or firm acquires ownership of used medical devices and restores these (devices) to the device manufacturer’s original or current specifications, for purpose of resale or commercial distributions.  The FDA points out that this definition is regulated because it is under the control of the original equipment manufacturer. I.e. an authorized facility or the original equipment manufacturer itself.  So, to be reconditioned, the device must have been reconditioned by the original equipment manufacturer or an authorized facility.

Remanufactured: Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. (Code of Federal Regulations, Title 21, Volume 8, Section 820.3.W)

As-Is/Used: For the purpose of resale or redistribution, the operational condition of the device is unknown.  The extent to which the device meets the operational requirements must be determined by the user prior to patient exposure.  The device may or may not be cosmetically enhanced.  As-Is/Used remarketers do not change a finished device’s performance or safety specifications, or intended use. (Federal Register, volume 62, number 246)

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