Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products. However, manufacturers may not be able to maintain control over their device after it leaves their hands, which can be a problem especially if the device is not repaired correctly or a third party changes the product. Stakeholders expressed concerns regarding the safety and effectiveness of medical devices that undergo one or more activities by a third party. FDA proposed adding seven definitions for third parties and the activities they perform on already-manufactured medical devices:
- Recondition: Restores and/or refurbishes a medical device to the OEM’s original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.
- Service: Maintenance or repair of a finished device after distribution to return it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
- Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
- Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.
- Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance, safety, specifications, or intended use.
- Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.