I have heard that the FDA will begin to regulate lab-developed tests (LDTs). Can you provide any information about this?


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 2021 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.