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FDA wants to know: what distinguishes 'service' from 'remanufacturing'?

By Robert J. Kerwin

The FDA has announced a public workshop on medical device servicing and remanufacturing, which will occur on December 10-11 in Washington, D.C. A guidance will likely be forthcoming after the workshop is completed and docket comments have been reviewed.

The intent of the public workshop is to discuss the distinction between medical device servicing and remanufacturing activities “to better inform the development of a future draft guidance.” The specific agenda for the workshop will be announced by November 26, 2018.

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The FDA will also be discussing opportunities for collaboration among medical device servicing and remanufacturing stakeholders. Although there will be opportunities for onsite registration on the day of the public workshop if time and space permit, it seems entirely possible (given the substantial public response to the March 2016 public workshop) that registration may close before the day of the workshop.

A white paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing” was issued by the FDA in conjunction with the workshop announcement and provides insight into what will be discussed.

Comments concerning the white paper and workshop will be accepted at https://www.regulations.gov in Docket No. FDA-2018-N-3741 until January 25, 2019.

Clarifying the difference between servicing and remanufacturing activities was one of the action items announced by the FDA in its Report on Servicing, released earlier this year. They are seeking feedback on whether stakeholders agree with the FDA-proposed Guiding Principles including whether there are additional considerations that may help companies distinguish servicing and remanufacturing activities.

Software and labeling are particular points of interest
The FDA’s discussion on software in its white paper is also worth reviewing, as demarcations and bright lines with respect to software changes are not as readily apparent. The white paper has set forth, with respect to software, that the FDA will consider identifying types of software changes that generally constitute servicing or remanufacturing. Among the issues to be explored are changes to software which may have unintended consequences, or the changes which otherwise have an impact as a result of the "cumulative" effect of the software changes. What may be "integral" to software will be explored. This is likely an area for which extensive input will be sought.
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