Medical Supply Chain Security Act
This bill requires manufacturers of essential medical devices (i.e., those that are life supporting, life-sustaining, or intended for use for a debilitating disease or condition) to notify the Food and Drug Administration (FDA) if the device is discontinued or if there is any meaningful disruption to the device's manufacturing. The bill also authorizes the FDA to expedite review of such a device to mitigate or prevent a shortage.
The bill also requires the manufacturer of an essential medical device or drug to report annually to the FDA certain information, such as details about all locations of production and the sourcing of component parts or active pharmaceutical ingredients.
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