FOOD AND DRUG ADMINISTRATION ISSUES RULE: REGULATION IDENTIFICATION NUMBER 0910-AJ05 MEDICAL DEVICES; LABORATORY DEVELOPED TESTS; IMPLEMENTATION OF VACATUR

WASHINGTON, Sept. 19 -- Food and Drug Administration has issued a rule called: Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur.

The rule was published in the Federal Register on Sept. 19 by Robert F. Kennedy, Secretary, Department of Health and Human Services.

Summary: On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.

For more information, contact Eitan Bernstein, Cen...