# Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
> **Food and Drug Administration** · Final rule. · Published 2025-09-19 · Effective 2025-09-19 · 90 FR 45134
## Document
- **Document number:** 2025-18239
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 45134
- **CFR reference:** 21 CFR 809
- **Publication date:** 2025-09-19
- **Effective date:** 2025-09-19
- **HHS docket:** Docket No. FDA-2025-N-1730
## 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation)
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