The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
Senator Rand Paul announced a resolution to repeal the FDA's LDT Final Rule, arguing it oversteps authority and threatens medical innovation.
Certain labs billed Medicare Part B for questionably high levels of add-on tests alongside COVID-19 tests in 2020.
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AACC issued a statement supporting the U.S. Congress’ exclusion of the VALID Act from its 2023 Omnibus Bill.
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The Association of Medical Pathology (AMP) applauded Congress for not including the VALID Act in the Consolidated Appropriations Act of 2023.
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The AACC is urging clinical lab professionals to write to their legislators to keep the VALID Act out of a Fiscal Year 2023 budget agreement.
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AMP is urging medical organizations to contact their elected officials to remove the VALID Act from a 2023 “omnibus” appropriations bill.
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The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
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The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
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Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
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The AACC joins more than 100 other organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act.
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In CLP’s July cover story, we’re examining how the proposed VALID regulations will affect the laboratory industry and society as a whole.
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The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.
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As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
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The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
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To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
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Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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