Devices

FDA Reverts Lab Test Reg. After Court Ruling

FDA has issued a final rule rolling back a 2024 regulation that expanded the agency’s authority over laboratory-developed tests (LDTs), following a federal court decision that struck down the earlier policy. The move restores the regulatory definition of “in vitro diagnostic products” to its pre-2024 language, removing a clause that explicitly included products manufactured by laboratories. That change, finalized in May 2024, was intended to clarify that FDA oversight extended to LDTs, a long-disputed area in clinical testing regulation.

The 2024 final rule regulating LDTs was vacated by Eastern Texas federal judge Sean Jordan, who ruled 3/31 in favor of plaintiffs American Clinical Laboratory Association and Association for Molecular Pathology, agreeing that the rule is in “excess of [FDA’s] statutory jurisdiction, authority, or limitations” and is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

FDA had maintained that the final rule was well within its authority under the Food Drug and Cosmetic Act (FDCA) and did not otherwise violate the Administrative Procedure Act. “In sum, Congress has considered but declined to enact several bills over the past two decades that would have reshaped the regulatory framework over laboratory-developed test services,” Jordan ruled. “Under the circumstances, agencies cannot circumvent, and courts must enforce, the statutory framework Congress enacted as it exists under the FDCA and CLIA [Clinical Laboratory Improvement Amendments].”

The court remanded the issue back to the Department of Health and Human Services for further review. In response, FDA says its latest final rule “reflects the court’s order vacating the rule” and formally deletes the laboratory-specific language from its regulations.

The legal battle over LDT oversight has been closely watched by the diagnostics industry, public health advocates, and lawmakers. Proponents of FDA regulation argue that agency oversight is necessary to ensure test accuracy and protect patients, while opponents — including many clinical laboratories — contend that FDA involvement is burdensome and unnecessary, given existing regulation under the Centers for Medicare and Medicaid Services.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome