FDA workshop: is it servicing or remanufacturing?

FDA workshop: is it servicing or remanufacturing?

by John R. Fischer, Senior Reporter | December 12, 2018
Parts And Service

“IAMERS believes in Collaborative Communities," said Upton. "In many ways IAMERS is a good example of ‘Collaborative Communities’. We have, as members, independent sellers and servicers, original equipment manufacturers, on-line sellers, and a variety of parts and specialty companies. We successfully communicate and do business with many stakeholders. For some of the guidance issues outlined by the FDA, we hope to see more C-suite participation to build on the trust and rapport.”

Looking ahead, AAMI president Rob Jensen said AAMI would be happy to act as the convener of a phone call with the stakeholders. Several panelists and those in the audience suggested additional parties who should be on the call, most notably healthcare organizations and the federal government stakeholders such as the VA. No specific date was set for the call.

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A white paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing” was issued by the FDA to provide additional insight into how they are approaching the discussion surrounding the definitions of servicing and remanufacturing.

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

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