FDA Makes Quality the Rule (continued)
11. SERVICING
The requirements of the section on servicing (subpart N) have changed dramatically since the 1995 working draft. This section no longer applies to third-party service providers, but only to manufacturers and remanufacturers that service devices they produce. FDA has stated in the preamble that it will address in a separate rule the application of servicing requirements to third-party service providers.
In addition, the final regulation has dropped the "end of life" terminology proposed in the 1995 working draft, as well as the proposed requirement that finished device manufacturers provide a device's safety and effectiveness specifications at initial sale or when requested by persons servicing it.
FDA has chosen not to define the term servicer, although it committed to do so in response to the GMP advisory committee meeting of September 1995. This definition would have included those who refurbish or rebuild finished devices as well as third-party service providers. Consequently, the best statement of FDA's position on the application of GMP requirements to those who recondition or rebuild devices is included in its Compliance Policy Guide (section 7124.28).2
With their inclusion in the quality system regulation, servicing requirements are now essential elements of a manufacturer's GMP program, and service requests must be screened for complaints and MDR reportable events. MDR reportable events are to be processed as complaints, and all other service reports may be trended as part of the manufacturer's corrective action program. If service requests reach a frequency that exceeds a firm's established action threshold, they must be investigated and processed according to the section on corrective action. Of course, any allegation concerning quality that meets the definition of a complaint (820.3(b)) must also be processed as a complaint.
All serviced devices must now meet "specified requirements" rather than "safety and performance specifications for the original intended use of the device(s)" as proposed in the 1995 working draft. This reflects FDA's understanding that due to use and age, a device may not meet original specifications but may be serviced to function as intended. The final rule specifies the minimum content of service reports.
