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Citation Edit

Safe Medical Devices Act of 1990, Pub. L. No. 101-629 (Nov. 28, 1990).

Overview Edit

The Act expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner.

The Act requires the FDA to determine the appropriate process for reviewing certain high-risk medical devices — either reclassifying certain high-risk medical device types to a lower-risk class or establishing a schedule for such devices to be reviewed through its most stringent premarket approval process.

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