The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
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Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more
On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of...more
FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach. On October 31,...more
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more
On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
Alabama became the 36th state to allow cannabis for medical use when Gov. Kay Ivey signed into law the Darren Wesley ‘Ato’ Hall Compassion Act on May 17, 2021. The act establishes a process through which applicants will...more
On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more
What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket...more
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more
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
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
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
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more