Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA
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