FDA Asks Industry About Difference Between Servicing and Remanufacturing

The FDA is seeking feedback from devicemakers to help craft guidance on the difference between servicing and remanufacturing devices.

The agency released a white paper outlining its initial thoughts about guiding principles and considerations for software and labeling, for discussion at a Dec. 10-11 public workshop.

Previous industry comments suggested that inadequate servicing of devices related to adverse events and deaths, but the agency maintains that they were a result of remanufacturing rather than servicing.

The FDA considers servicing as the repair or preventative maintenance on a finished device after distribution to return it to the specifications established by the original equipment manufacturer to meet its original intended use. Remanufacturing is processing, conditioning, renovating, repacking, restoring or any act done to a finished device that significantly changes the device’s performance or safety specifications or intended use.

There is an overlap between the regulatory definition of remanufacturing and the standard for when a 510(k) is required for a change to a legally marketed device, which could change safety or effectiveness in the intended use, the FDA said.

The agency is seeking comment on the following proposed guiding principles:

• Servicing does not significantly change the safety or performance specifications of a device;
• Evaluate whether any changes to a device require a new 510(k);
• Assess component/part/material dimensional and performance specifications. Assessment of changes to dimensional specifications can inform whether the activity performed is servicing or manufacturing;
• Employ a risk-based approach when assessing whether an activity is servicing or remanufacturing. An activity performed on a device is likely remanufacturing when a risk-based assessment identified any new risks or significantly increases known risks, and thus significantly changes performance or safety specifications or intended use; and
• Adequately document decision-making to explain why a determination is made. Documentation should specify why activities performed don’t significantly change the performance or safety specifications or intended use of a marketed device.

The white paper also discusses includes an appendix of definitions. Comments on the paper may be submitted until Jan. 25, 2019.

Read the white paper here: www.fdanews.com/11-01-18-WhitePaper.pdf.