This summary highlights the key provisions with implications for children’s health and health care in the FDA final rule “Medical Devices; Laboratory Developed Tests.” The rule requires most laboratory developed tests (LDTs) to go through the FDA medical device review process, phasing in those requirements over five years beginning May 6, 2025.
The rule includes some partial exceptions to the regulatory review process for certain types of tests, including some tests conducted by children’s hospitals:
- LDTs manufactured and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within that system.
- Currently marketed LDTs that are not modified or that are modified in certain limited ways.
- LDTs approved by the New York State Clinical Laboratory Evaluation Program.
