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.

Summary

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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3 official files

• Introduced in House (text)

  Introduced in House · EN · 3 March 2020

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• Introduced in House (PDF)

  Introduced in House · EN · 3 March 2020

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• Introduced in House

  summary · EN · 3 March 2020

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