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FDA Introduces ‘Proactive‘ Resilient Supply Chain Program To Reduce Future Device Shortages

 
• By Brian Bossetta

The US FDA’s Resilient Supply Chain Program (RSCP) will be housed in the agency’s Office of Strategic Partnerships and Technology Innovation and aims to reduce future supply chain shortages by applying lessons learned during the pandemic.

Shipping Port
• Source: Shutterstock

In her keynote address during a virtual public workshop on 8 June, Tammy Beckham, the associate director for the Food and Drug Administration’s Resilient Supply Chain Program (RSCP), stated the obvious: The medical supply chain is complex and vulnerable to a variety of events that can result in significant shortages of critical devices and equipment when they are needed most.

The increased demand for personal protective equipment and ventilators during the COVID-19 pandemic comes to mind, but recent weather events, accidents involving cargo ships at sea, and ongoing geo-political crises...

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More from Regulation

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

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UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

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Zika Virus Test Among 4 New FDA Device Classifications

 
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More from Policy & Regulation

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

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Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel