The Food and Drug Administration (FDA) has faced significant opposition, with over 19,600 comments received during the public comment period for its proposed changes to the oversight of laboratory developed tests (LDTs). Leading the resistance is the American Clinical Laboratory Association (ACLA), submitting a 107-page document expressing “grave concerns” and urging the FDA to withdraw the proposal. The American Hospital Association (AHA) and other healthcare provider groups also opposed the plan, arguing that it could limit patient access to tests.
Despite calls for an extension of the comment period, the FDA closed it on Monday. Stakeholders are particularly concerned about plans to increase regulatory oversight of LDTs without additional powers from Congress. The ACLA, representing companies like Labcorp and Quest Diagnostics, emphasized that the imposition of medical device authorities on LDTs could hinder patient access and stifle diagnostic innovations.
A total of 19,655 comments were submitted, with various groups expressing opposition to the proposed rule. The AHA urged the FDA to maintain its current enforcement discretion approach, stating that regulating LDTs as medical devices would negatively impact patient access to essential testing. Other groups, such as the Pan American Society for Clinical Virology and Vanderbilt University Medical Center, raised similar concerns about the regulatory structure’s suitability for independent clinical laboratories and potential limitations on access to tests.
AdvamedDx, representing companies producing in-vitro diagnostic tests, acknowledged the FDA’s authority to regulate LDTs as medical devices but emphasized the need for comprehensive regulatory reform. The comments highlighted the benefits of the VALID Act, bipartisan legislation aimed at overhauling test regulation, though its passage through Congress has been challenging.
The diverse range of stakeholders expressing concerns underscores the complexities and potential ramifications of the FDA’s proposed changes to the oversight of LDTs.