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PCCPs Can Help Speed Device Sterilization Changes, FDA Webinar Suggests

 
• By Elizabeth Orr

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.

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Device developers who want to use a Predetermined Change Control Plan (PCCP) during the US Food and Drug Administration’s premarket review process shouldn’t skimp on the detail, FDA officials say.

“A good rule of thumb is that generally, the level of detail expected in a PCCP should be the same...

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FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
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Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.