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Regulatory Oversight › Clinical Laboratories › Centers for Medicare & Medicaid Services (CMS)

Morgan Lewis

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

Morgan Lewis on

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

Wilson Sonsini Goodrich & Rosati

Administrative Notice Limits the FDA's Ability to Regulate Laboratory Developed Tests, Including COVID-19 Tests

Wilson Sonsini Goodrich & Rosati on

Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more

Seyfarth Shaw LLP

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

Seyfarth Shaw LLP on

In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

Hogan Lovells

Senate bill proposes laboratory developed tests to be regulated under CLIA process

Hogan Lovells on

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

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