To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes.
About This Bill
Introduced
Latest Action · March 4, 2020
Sponsor introductory remarks on measure. (CR H1476)
This bill expands existing requirements relating to supply shortages of life-saving drugs to also apply to life-saving medical devices.
Generally, a manufacturer must (1) notify the Food and Drug Administration (FDA) of supply interruptions in certain circumstances, (2) provide for the expedited review of a new device that may mitigate the shortage, and (3) allow the FDA to authorize the importation of the device for emergency medical care.
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