FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
This article was originally published in The Gray Sheet
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.
You may also be interested in...
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
A group of infectious disease and clinical virology societies are asking FDA to establish an alternative under the agency's proposed lab-developed test framework for infectious disease test services. Clinical laboratories should be able to use commercial high-risk tests as predicates for ID LDTs so they won't have to go through the costly PMA submissions process.
Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.