The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point. Last week, the agency made the draft rule public, prior to its official publication this week. This move by the FDA—which picked up significant momentum over […]
FDA Releases Proposed Rule to Further Regulate LDTs
Also in the October, 2023, issue, the history of the FDA's proposal is outlined
- By Robert Michel
- > From the Volume XXX, No. 14 - October 2, 2023 Issue
