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FDA Updates Slew Of Radiology Guidance Documents

 
• By Elizabeth Orr

The US Food and Drug Administration has released revised versions of six guidance documents to reflect new x-ray reporting requirements, among other changes.

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In a flurry of regulatory activity, the US Food and Drug Administration on 21 February released six guidance documents setting new performance or compliance standards for devices that use radiology. The changes made to the documents include revisions to harmonize with international standards or remove outdated reporting requirements.

An issue at the heart of multiple documents is reconciling FDA regulations with similar, but not identical, international standards. For example, the agency’s standards for laser products don’t quite line...

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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• By Amanda Maxwell

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• By Ashley Yeo

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More from Policy & Regulation

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• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

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