Home / Agencies / FDA / 2025-18239
Final Rule

Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur

Agency
FDA
Document Number
2025-18239
Published
September 19, 2025
Effective Date
September 19, 2025

Abstract

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.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2025-18239 Federal Register document?
Document 2025-18239 is a Final Rule published by the Food and Drug Administration in the Federal Register on September 19, 2025, with an effective date of September 19, 2025. 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. View the original at https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation.
Is document 2025-18239 an economically significant rule?
No. Document 2025-18239 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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