The Safe Medical Devices Act was passed
On Nov. 28, 1990, the Safe Medical Devices Act was passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizeed the FDA to order device product recalls and other actions.
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Source: U.S.Congress
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