💉FDA Regulation Vacatur and Its Impact on Laboratory Developed Tests
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation impacts businesses involved in laboratory-developed tests (LDTs) as it reverts changes to definitions that may affect compliance costs and regulatory burdens. The vacatur of the previous rule leads to significant cost savings for the industry, with estimated annualized savings of approximately $1.44 billion, indicating potential improvement in profitability for affected parties.