A new diagnosis

FDA has given up on the idea that diagnostic tests can be shoehorned into the medical device regulatory paradigm, and has asked Congress to create a new framework for oversight.

Like FDA’s initiatives to revamp the regulation of regenerative medicines and digital health, and to prod industry into adopting more innovative clinical trial designs, the agency’s diagnostics framework is intended to ease regulatory bottlenecks that have prevented the translation of scientific advances into medical products. And like the other areas, FDA’s diagnostics framework replaces a start-and-stop regulatory model with one that is designed to match the speed of scientific advances...