Because of the apparent confusion between servicing and remanufacturing, FDA committed in the FDA Report on Device Servicing to issue guidance that clarifies the difference between servicing and remanufacturing activities. To assist with this clarification, FDA focuses this guidance on those activities that are likely remanufacturing.
This guidance addresses activities performed on devices that are intended to be reused and maintained. This guidance discusses whether activities performed by OEMs and third parties on such devices are likely remanufacturing. This guidance is not intended to adopt significant policy changes, but to clarify FDA’s current thinking on applicable definitions, and clarify, not change, the regulatory requirements applicable to remanufacturers. The concepts in this guidance are also not intended to alter or supersede existing regulations and policies related to the regulatory threshold for submitting a marketing submission for a device.
The products included within the scope of this guidance are devices as defined in section 201(h) of the FD&C Act, including software and electronic products that meet the definition of a device.
In general, the concepts discussed in this guidance are meant to apply to all reusable devices, irrespective of their classification into class I, II, or III, including those subject to premarket approval. This guidance is not intended to address reprocessed single-use devices.