
Proposed Center Within FDA Could Streamline Approval Process for Lab-Developed Tests
The House Energy and Commerce Committee is drafting language that will help create an in vitro center within the FDA to define risk categories for laboratory-developed tests (LDTs), and set timelines to accelerate the approval process for LDTs.
Regulation of laboratory-developed tests (LDTs) has been vigorously debated for a while now, especially after the FDA
Reactions following the announcement were
Now, the House Energy and Commerce Committee (E&C) has developed a bill that classifies LDTs based on their characterization and the impact of an adverse result on public health. Additionally, timelines set within the bill would help accelerate the review/approval process within the FDA to improve public access to the tests. While the committee had a placeholder for LDTs in the original
While the final decision for approving or rejecting the LDT lies with the FDA, they have to provide the test-developer the rational behind their decision within a 60-day period. While establishing clinical utility is not a requirement for high-risk tests, manufacturers/developers have to ensure analytical and clnical validity of the test. Moderate-risk tests, the bill proposes, would only need data supporting analytical validity, and a "reasonable belief" that it is clinically valid for its proposed use.
The E&C draft's proposed “Center for In Vitro Clinical Tests” would be responsible for the implementation of the new regulatory structure.
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