COVID Laboratory Testing Investigations
During and after the COVID-19 Public Health Emergency, the Centers for Medicare & Medicaid Services (CMS) provided certain flexibilities and exercised enforcement discretion with respect to regulations affecting...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2025. Regulators are signaling clear priorities: stronger enforcement, modernization of compliance standards,...more
The Pennsylvania Department of Health, Bureau of Laboratories (the Bureau) recently issued a host of new guidance and forms related to licensure and operation of clinical laboratories located in Pennsylvania and/or receiving...more
The Centers for Medicare and Medicaid Services (CMS) announced that the Clinical Laboratory Improvement Amendments (CLIA) program will be paperless as of March 1, 2026. After this date, CMS will no longer send paper fee...more
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that. Multiple lawsuits were...more
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. ...more
On October 1, 2025, the CMS Center for Clinical Standards and Quality issued a memorandum outlining its contingency plans regarding state survey and certification activities in light of the federal government shut down. The...more
The United States Food and Drug Administration (FDA) has officially rescinded its final rule proposing to regulate Laboratory Developed Tests (LDTs) as medical devices. On Sept. 19, 2025, FDA issued a new final rule reverting...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more
Governor Newsom signed over 1300 bills and vetoed almost 190 bills in 2024. Consistent with prior years, in 2024, California enacted multiple laws significantly impacting the health care industry. From artificial intelligence...more
On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. LDTs are laboratory tests that are designed,...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act...more
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more
The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more