CLIA ID #: 34D2295704

CAP ID # 983112501

Carolina Diagnostic Labs Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices.

Carolina Diagnostic Labs is committed to standing strong for our patients and clients during these challenging times. We understand the importance of providing essential services to those in need, and we will continue to do so without fail. Despite the recent setback caused by the FDA’s new rule, we remain steadfast in our commitment to providing the highest quality services to our patients and clients.

The FDA’s new rule to regulate laboratory-developed tests as medical devices denies the opportunity for collaboration on an oversight framework aligned with clinical laboratory expertise and resources. This has left many stakeholders in the clinical testing industry disappointed and concerned about the future of patient protection and innovation.

However, Carolina Dx is dedicated to navigating these challenges and working towards a better future for all. We will continue to provide essential services to those in need and stand strong for our patients and clients.