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FDA Establishes New Medical Device Category

FDA Establishes New Medical Device Category

FDA Authorization Now Required to Market UV Robots to Healthcare Facilities

Newswise — The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present.

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