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.
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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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H1476)
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H1476)
Health
Drug safety, medical device, and laboratory regulationHealth technology, devices, supplies
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.
USA116th CongressHR-6062| House
| Updated: 3/4/2020
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.