FDA Plan To Regulate Lab-Developed Tests Includes Long Phase-In, Unmet-Need Exceptions
This article was originally published in The Pink Sheet Daily
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved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...
The House Energy and Commerce Committee is seeking feedback on initiatives Congress should enact in 2015 regarding regulation of diagnostics, and in particular in response to FDA's plan to regulate laboratory developed tests.
Several Democratic Senators want the Office of Management and Budget to release the FDA draft guidance on lab-developed tests that has been stuck at OMB for years. Academic clinical labs send their own letter to the budget office, pleading that the guidance not be released.
Although FDA is still developing its lab-developed test regulatory framework, it has agreed not to collect user fees to support its planned review of the tests.