A new diagnosis

FDA wants to create a new way to regulate diagnostics

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.

In FDA documents obtained by BioCentury, the agency outlines a new model in which most diagnostics could be marketed without premarket clearance, sponsors would be able to continuously improve tests with few regulatory hurdles, and the bulk of oversight would shift to postmarket.

To make it happen, FDA says it needs more authority to request postmarket data and power to withdraw tests from the market if sponsors do not provide requested data or if FDA has evidence that tests do not

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