Research ReportCRS InsightVersion 2
IN11548
HHS Announcement on FDA Premarket Review of Laboratory-Developed Tests (LDTs)
Published Dec 3, 2020Updated Jun 20, 2025
Full report
What this is
The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.