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Recall Effectiveness Checks: FDA Tips

 
• By Shawn M. Schmitt

Conducting device recall effectiveness checks can be tricky. Two FDA officials offer advice to make the process work smoother and explain why Unique Device Identification will be helpful in this month’s “Compliance Corner.”

The lynchpin of a good product recall effectiveness check is ensuring adequate documentation, an FDA recall coordinator says.

Effectiveness checks happen when companies contact product users to make sure they know that a recall is underway. They also...

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Injuries And Deaths Linked To Baxter Infusion Pump

 
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Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

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

 
• By Brian Bossetta

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More from Policy & Regulation

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

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.