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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 The changes made to the documents include revisions to harmonize with international standards or remove outdated reporting requirements.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...

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