2. The FDA has estimated approximately 16,000 to 20,000 entities are engaged in servicing activities. How will the FDA promote compliance with the guidance by those entities who consider themselves as only servicers, but who may in fact also be involved in remanufacturing?
3. What surveillance mechanisms are available to the FDA to detect servicers who are also performing remanufacturing?
4. What actions does the FDA currently take if it identifies unregistered entities engaged in remanufacturing? What, if any, new options for action are under consideration?

“We applaud Senators Warren and Cassidy’s attention to this very important issue,” said Dennis Durmis, SVP, radiology head of Americas region at Bayer and chair of the MITA board of directors, in a statement. “Organizations that are engaged in servicing and remanufacturing are looking to the FDA to make clear the differences between the two activities.”

The FDA plans to address the issue in its 2020 proposed guidance list, which is expected for release next September.

Warren’s office did not respond for comment.

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