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October 25, 1985

Device center regulates 'tools of the trade'

JAMA. 1985;254(16):2243-2244. doi:10.1001/jama.1985.03360160073012

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Last March, a young man in Tucson underwent the second of three operations in a two-day marathon of ultimately unsuccessful attempts to save his life. The patient's immune system had acutely rejected a human heart transplanted just hours before, and now his surgeons needed to borrow time until another human heart could be found. They chose to implant an artificial heart.

But the device wasn't the federally sanctioned Jarvik-7 artificial heart. Nor had this "Phoenix heart," named for the city in which it was developed, been tested before in humans. In fact, it had only been tested in calves for up to 12 hours. But not filing for government approval for the heart, as stipulated by the 1976 medical device amendments to the Food, Drug, and Cosmetic Act of 1938, the surgeons had apparently defied the FDA.

Or had they? According to John C. Villforth, MS, director of the FDA's