Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

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

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 Read More »

To access this post, you must purchase The Dark Report.



You are reading premium content from The Dark Report, your primary resource for running an efficient and profitable laboratory.

Get Unlimited Access to The Dark Report absolutely FREE!

You have read 0 of 1 of your complimentary articles this month

Privacy Policy: We will never share your personal information.