Two members of the U.S. Senate have penned a letter to acting U.S. FDA Commissioner Ned Sharpless to express their "continued interest" in the efforts to publish a guidance on the remanufacture and servicing of radiology equipment, one of the entries on the agency's guidance agenda for fiscal 2020. The authors of the letter, Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) said they were encouraged by the agency's action to distinguish between servicing and remanufacturing but asked how the agency intends to identify the universe of service providers to whom remanufacturing requirements would apply. They also asked how the agency will promote compliance, as well as how it would erect surveillance mechanisms to ensure it has identified entities that are engaged in radiology system remanufacture. Cassidy and Warren requested that Sharpless respond by Nov. 1.

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