The FDA's proposed rule aims to end enforcement discretion for laboratory-developed tests (LDTs) and regulate them as commercial in vitro diagnostics (IVDs). This proposal outlines a five-stage implementation process over four years, starting with general enforcement discretion for medical device reporting and ending with the regulation of high-risk tests. The authors argue that LDTs, developed by individual clinical laboratories, should not be regulated like commercial IVDs. They highlight concerns such as the lack of infrastructure at the FDA and in laboratories to support the required submissions, the potential stifling of diagnostic innovation, and the negative impact on health equity. The authors suggest that a registration process and non-burdensome adverse event reporting would be more appropriate initial steps to understand the scope and safety of LDTs. They emphasize the importance of patient safety, accurate diagnostics, and health equity in the regulatory framework. The proposed rule's strict approach, without grandfathering or exemptions, could negatively affect the ability of laboratories to innovate and provide timely, accurate testing, particularly for infectious diseases and emerging pathogens.The FDA's proposed rule aims to end enforcement discretion for laboratory-developed tests (LDTs) and regulate them as commercial in vitro diagnostics (IVDs). This proposal outlines a five-stage implementation process over four years, starting with general enforcement discretion for medical device reporting and ending with the regulation of high-risk tests. The authors argue that LDTs, developed by individual clinical laboratories, should not be regulated like commercial IVDs. They highlight concerns such as the lack of infrastructure at the FDA and in laboratories to support the required submissions, the potential stifling of diagnostic innovation, and the negative impact on health equity. The authors suggest that a registration process and non-burdensome adverse event reporting would be more appropriate initial steps to understand the scope and safety of LDTs. They emphasize the importance of patient safety, accurate diagnostics, and health equity in the regulatory framework. The proposed rule's strict approach, without grandfathering or exemptions, could negatively affect the ability of laboratories to innovate and provide timely, accurate testing, particularly for infectious diseases and emerging pathogens.