FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.