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US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

 
• By Shawn M. Schmitt

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Mark your calendar: US FDA investigators will begin inspecting device manufacturing facilities using the agency's brand-new "program alignment" inspectional approach on May 15.

That's according to Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health, who...

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Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
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Experts Call For Database Of Medical Device Labels

 
• By Elizabeth Orr

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

More from Policy & Regulation

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

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Bates To Energize UK Office For Life Sciences

 
• By Ashley Yeo

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

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.