Rep. Finstad and Rep. Crenshaw Introduce Resolution Against FDA Rule Restricting Access to Laboratory Developed Tests
As the laboratory community continues to voice concerns regarding the LDT ruling, we find more lawsuits and resolutions being filed to challenge its implementation.
U.S. Congressman Brad Finstad and Dan Crenshaw highlight the following as having the most significant impact under the FDA’s new rule:
- Impose regulatory burdens that hinder the development and deployment of new and improved lab-developed tests;
- Increase regulatory requirements that will lead to delays in patients’ access to critical diagnostic tests;
- Potentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and,
- Negatively impact small and medium-sized laboratories, which will face economic challenges with complying with the rule as written.
You can read more about the press release here.