Question:
I have heard that the FDA will begin to regulate lab-developed tests (LDTs). Can you provide any information about this?
Answer:
Recently, Congress has issued bipartisan draft legislation referred to as the Verifying Accurate, Leading-edge In Vitro Clinical Test Development (VALID) Act, which has stirred up some controversy among industry associations. This bill details the framework for the Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) for in vitro clinical tests (IVCTs). The latest version added major ideas from the FDA such as a precertification program for both areas.
This question was answered in an edition of our Laboratory Compliance Manager. For more hot topics relating to laboratory services, please visit our store or call us at 1.800.252.1578, ext. 2.
CPT® copyright 2024 American Medical Association (AMA). All rights reserved.
Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
CPT is a registered trademark of the American Medical Association.
Subscribe to receive our News, Insights, and Compliance Question of the Week delivered right to your inbox.
Address:Â 5874 Blackshire Path, #13, Inver Grove Heights, MN 55076
Phone:Â (800) 252-1578
Email:Â support@medlearnmedia.com
Hours:Â 9am – 5pm CT
Copyright © 2025 MedLearn Publishing. Powered by MedLearn Media.
Unlock 50% off all 2024 edition books when you order by July 5! Use the coupon code CO5024 at checkout to claim this offer!
CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24Â