Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
fda-device · Food and Drug Administration · Rule · Published 2025-09-19 · Effective 2025-09-19 · 90 FR 45134
Document
Document number
2025-18239
Federal Register citation
90 FR 45134
CFR reference
21 CFR 809
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.