FDA rolls out long-awaited proposal to overhaul diagnostics regulation
The FDA on Friday unveiled a long-awaited proposed rule that aims to overhaul how the agency regulates diagnostic tests, bringing thousands of new tests under its purview.
The 83-page proposed rule makes explicit that in vitro diagnostics would be regulated as medical devices in the eyes of the FDA, and it would phase out its enforcement discretion approach for laboratory-developed tests (LDTs) over a period of four years. The rule fulfills FDA officials’ commitments in recent months to pursue rulemaking to overhaul the agency’s framework for regulating diagnostic tests in the absence of congressional action.
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