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Masks And Gowns Off FDA Device Shortage List, But AEDs Among Devices Added

 
• By Brian Bossetta

The US agency has updated it device shortage list, adding two devices to the list of products in short supply while removing two others.

PPE Box
• Source: Shutterstock

The US Food and Drug Administration has updated its device shortage list to reflect that two and a half years into the COVID-19 pandemic, the country finally has enough personal protective equipment to meet demand.

On 19 July, the agency removed medical gowns (product codes FME, FYA, and OEA) and surgical masks (product code FXX)...

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• By Natasha Barrow

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International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

More from Policy & Regulation

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

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From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.