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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,...

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More from Regulation

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 
• By Amanda Maxwell

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.