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QUOTED. Dec. 14, 2018. Aaron Josephson.

A revised bill circulating in both the US House and Senate would revamp FDA regulation of diagnostics to create a pre-certification process to validate test developers.

Quoted

"Two key features of the bill that are likely to appeal most to diagnostic companies are pre-certification and review by accredited persons (i.e., third party review), both of which have to the potential to minimize FDA review, which is considered by some to be burdensome,” - Aaron Josephson, Senior Director, ML Strategies

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