Diagnostics Reform Reintroduced in House
The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
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Hillebrenner Fields Questions On FDA’s Proposed Rule To Regulate LDTs, Says No To Extended Comment Period
During a recent webinar, Elizabeth Hillebrenner of the US FDA’s device center sought to clarify specifics on the agency’s proposed rule to regulate laboratory-developed tests, which establishes FDA oversight of the tests over a five-year period.
Stakeholders are still processing the US FDA’s proposed rule that would place lab-developed tests under its regulatory purview. While only time will tell what it all means, it is already clear that the agency’s action, if finalized, will significantly affect the healthcare industry and above all patients.
During a webinar hosted by the Alliance for a Stronger FDA, commissioner Robert Califf said the agency was on the path to using its rulemaking authority to regulate laboratory-developed tests.