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FDA Week - 08/10/2018

Device Makers: FDA Expands On Concepts In Lab Test Oversight Bill Draft

August 09, 2018
Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review. In technical assistance sent at lawmakers' request on Aug. 3, FDA suggests the following specific revisions to the draft bill, Diagnostic...


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