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If an Italian design-engineering company which manufactures and constructs new hospital operating rooms, chemotherapy labs, dialysis labs, etc. wants to open a subsidiary in the United States, would they need FDA approval for any component of the construction materials? For example, the walls that they use clip on to a metal framework, and those walls have anti-microbe features on the surfaces. Would the walls need FDA approval? What other certifications might they need to operate in the U.S.? Thanks!