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.
"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