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FDA Looking To Streamline Sterilization Submissions Through Bundling, PCCPs

 
• By Hannah Daniel

The FDA’s fourth town hall on sterilization reviewed the agency’s Master File Pilot Programs, the use of PCCPs for sterilization changes and the process for bundling multiple sterilization change 510(k)s.

• Source: Shutterstock

The US Food and Drug Administration is looking into streamlining the premarket review process for sterilization, which includes bundling 510(k)s that are submitted when a company changes its sterilization method.

Scott Steffen, ethylene oxide (ETO) incident lead at the Division of All Hazards Preparedness & Response in the Office of...

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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.