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Fewer Medical Device Shortages: New Rules for Manufacturers

This act aims to reduce shortages of essential medical equipment in hospitals and clinics. It mandates that manufacturers develop risk management plans for their supply chains, ensuring a steady availability of critical devices. This change should provide citizens with greater peace of mind regarding access to necessary medical equipment in healthcare facilities.
Key points
Medical device manufacturers are now required to create risk management plans to prevent shortages.
Information about medical device shortages will be reported regardless of whether a public health emergency is declared.
Authorities can request voluntary information from manufacturers about their supply chains to better monitor the situation.
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Additional Information
Print number: 118_HR_3807
Sponsor: Rep. Castor, Kathy [D-FL-14]
Process start date: 2023-06-05