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New FDA Supply Chain Program Aims To Prevent Device Shortages

The new program will be the focus of the agency’s June workshop

 
• By Brian Bossetta

The US Food and Drug Administration is building a new Resilient Supply Chain Program, which aims to bolster the nation’s supply of essential medical devices and prevent future shortages.

COVID-19 Cargo
• Source: Alamy

If any lesson has been learned from the COVID-19 pandemic, it’s the need to have a reliable supply of essential medical supplies at the ready.

In the early stages of the pandemic basic personal protective equipment (PPE) such as masks were in short supply, as...

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More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.