The FDA proposed a rule to end enforcement discretion for laboratory-developed tests (LDTs), aiming to regulate them like commercial in vitro diagnostics (IVDs). This rule would require LDTs to undergo pre-market review, potentially impacting clinical and public health laboratories. The authors argue that LDTs should not be regulated the same as commercial IVDs, as they are already regulated under CLIA and provide critical diagnostic services. They express concerns that the rule would stifle innovation, reduce access to testing, and harm health equity. The FDA's approach is criticized for lacking a clear definition of LDTs, not accounting for the unique role of laboratories in developing and validating tests, and failing to consider the infrastructure and resources needed for compliance. The authors also highlight the importance of LDTs in addressing diagnostic gaps and the potential negative impact of the rule on patient care, especially in underserved areas. They advocate for a data-driven approach that balances regulatory oversight with the need for innovation and accessibility. The proposed rule may also lead to increased reliance on reference laboratories, delaying results and reducing access to testing. The authors emphasize the need for a regulatory framework that supports the development and use of LDTs while ensuring patient safety and health equity.The FDA proposed a rule to end enforcement discretion for laboratory-developed tests (LDTs), aiming to regulate them like commercial in vitro diagnostics (IVDs). This rule would require LDTs to undergo pre-market review, potentially impacting clinical and public health laboratories. The authors argue that LDTs should not be regulated the same as commercial IVDs, as they are already regulated under CLIA and provide critical diagnostic services. They express concerns that the rule would stifle innovation, reduce access to testing, and harm health equity. The FDA's approach is criticized for lacking a clear definition of LDTs, not accounting for the unique role of laboratories in developing and validating tests, and failing to consider the infrastructure and resources needed for compliance. The authors also highlight the importance of LDTs in addressing diagnostic gaps and the potential negative impact of the rule on patient care, especially in underserved areas. They advocate for a data-driven approach that balances regulatory oversight with the need for innovation and accessibility. The proposed rule may also lead to increased reliance on reference laboratories, delaying results and reducing access to testing. The authors emphasize the need for a regulatory framework that supports the development and use of LDTs while ensuring patient safety and health equity.