"MITA is planning on submitting comments to that docket," said Weems. "I think that that workshop, as well as the responses to the docket, will inform a guidance that the agency has indicated it will put out in fiscal year 2019, which will draw a brighter line between servicing and remanufacturing activities for medical devices."

A white paper, entitled “Evaluating Whether Activities are Servicing or Remanufacturing”, for guidance on medical device servicing was released in the fall of 2018 and opened up for public commentary. Initially set for January 25, the deadline for submitting written comments was pushed back one month to February 25.


Comments may be submitted until then at https://www.regulations.gov in Docket No. FDA-2018-N-3741.

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