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Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 'In The Coming Years,' Official Says

 
• By Shawn M. Schmitt

The US agency's 22-year-old bedrock rule for making safe and effective medical devices to be sold in the United States will likely be replaced with international quality systems standard ISO 13485, FDA official Sean Boyd said at MedCon 2018. But the author of the Quality System Regulation, Kim Trautman, told Medtech Insight that it would be a thorny, years-long chore for the agency.

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FDA's Quality System Regulation – the bedrock rule for manufacturing safe and effective medical devices to be sold in the United States for more than two decades – will likely be replaced with international quality systems standard ISO 13485, an agency official says.

Sean Boyd, deputy director for regulatory affairs for the Office of Compliance within FDA's Center for Devices and Radiological Health,...

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