Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs
A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion
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As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.
The FDA expects that outside reviewers will be able to handle about half of all lab-developed test submissions, a spokesman told Medtech Insight. Meanwhile, a recent CDRH memo discussing COVID-19 test validation offers further background on why the agency is concerned about LDT accuracy and reliability.
Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October.