CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LDTs) goes back at least to 2014. That’s the year when the FDA first issued a notice to Congress that it intended to regulate LDTs. Even […]
FDA’s Road to Regulation of Lab Developed Tests
It’s been a lengthy, nine-year journey by the FDA to establish authority to oversee lab developed tests
- By Robert Michel
- > From the Volume XXX, No. 14 - October 2, 2023 Issue
