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 →

Opens in new tab · federalregister.gov

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.

Other Rules from FDA

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
Proposed · Nov 2025
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
Proposed · Nov 2025
Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
Proposed · Nov 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
Final Rule · Sep 2025
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
Final Rule · Sep 2025
Radiological Health Regulations; Technical Amendments
Final Rule · Sep 2025
View all Food and Drug Administration rules →

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official state legislatures, IAPP, NCSL, and federal regulatory trackers. See our methodology for details. Retrieved and formatted by PlainRegWatch Editorial

Every figure on PlainRegWatch is rendered directly from state source data, no number is typed in by an editor. This page draws directly on federal and state source data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.