Yes, it is the rough equivalent. It approves medical devices for the entire U.S. There are no separate regulatory boards at the state level. However, some states have certificate of need programs that regulate the proliferation of medical devices. The issue is not whether Device X is clinically useful or safe, but instead how many and which institutions can purchase them for use. The concern is to avoid duplication of expensive medical equipment such as MRI machines, lithotripters and similar devices. But the same process is used in some states to regulate the number, types and distribution of hospital and/or nursing home beds, not just medical equipment.