FDA Lays Out Requirements For Diagnostic Radiology Display 510(k)s
This article was originally published in The Gray Sheet
The draft guidance, which will replace a 2008 document, details FDA expectations for device descriptions and bench testing, including where they differ for mammography and non-mammography products.
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US FDA's 14-page guidance, issued Oct. 2, outlines the agency’s recommendations for 510(k)s seeking clearance for the viewing units used in diagnostic radiology, finalizing a 2016 draft guidance.
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