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Preventing Medical Device Shortages: New Reporting Rules

This act aims to ensure that hospitals and patients always have access to essential medical devices, such as life-sustaining equipment. It introduces new rules requiring manufacturers to report potential supply issues, allowing for quicker responses and prevention of shortages. This helps citizens feel more secure, knowing that critical medical devices will be available when needed.
Key points
Manufacturers of medical devices, especially life-saving ones, must report when they plan to stop production or when supply interruptions may lead to shortages.
Companies producing critical medical devices must develop risk management plans to prevent supply disruptions, enhancing access to equipment.
The government will regularly report on how it uses this data to prevent shortages, increasing transparency.
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Additional Information
Print number: 117_S_3477
Sponsor: Sen. Casey, Robert P., Jr. [D-PA]
Process start date: 2022-01-11