Patient, Consumer, and Public Health Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests

December 4, 2023

Docket No. FDA-2023-N-2177

As members of the Patient, Consumer, and Public Health Coalition, we are writing to strongly support the FDA’s proposed rule entitled Medical Devices; Laboratory Developed Tests, with the exception of FDA’s proposed increased use of third-party reviewers.

We strongly support FDA’s conclusion that it has the authority to regulate all in vitro diagnostic tests, including laboratory-developed tests (LDTs), under the Federal Food, Drug, and Cosmetic Act (FD&C Act). We agree with the proposed policy to phase out its current enforcement discretion approach for LDTs.  It is our understanding that FDA would use the same risk-based enforcement approach that the agency currently uses for other diagnostic tests. Many patients are currently being irreparably harmed by inaccurate LDTs, and all patients deserve to be able to rely on the accuracy of diagnostic tests.  For these reasons, we urge the FDA to phase out enforcement discretion as quickly as possible, with priority to the LDTs with the greatest implications for patients’ health and well-being.


The proposed rule provides an example of an inaccurate test developed by an Academic Medical Center, which had validated its COVID-19 diagnostic test based only only 12 positive samples.  However, the results were substantially less accurate when the FDA requested evaluation of 12 additional samples.  Fortunately, the Emergency Use Authorization for that LDT was withdrawn. However, the important point of that example is that Academic Medical Centers should be treated like any other laboratories, to ensure that patients are protected from inaccurate test results.

FDA first proposed regulating LDTs in a 2014 draft guidance that was never finalized.  Despite our best efforts, Congress has repeatedly failed to pass legislation that would establish a regulatory framework for these tests and the resources needed to implement it.  We are grateful that the FDA has decided to move forward rather than waiting for Congress, and will work to educate the public about the need for FDA to have the resources needed to ensure LDTs are appropriately reviewed and regulated.  This includes the need for additional staff so that the scientific reviews are conducted by well-trained scientific staff at the FDA, rather than third party entities who are paid by the companies and therefore have an inherent conflict of interest.  As is true in other situations, when a company’s survival depends on keeping their customers happy, the company has a vested interest in providing the service that the customers want.  In this case, laboratories want FDA approval or clearance so that they can sell their products, which is why scientific reviews should be conducted by FDA staff who are paid by U.S. taxpayers and not reliant on pleasing the laboratories.

The FDA has asked for comments on whether there is a public health rationale for a longer phase-out period for smaller laboratories.  On the contrary, the phase out period is already long, and that will harm patients. The appropriate public health rationale is that all laboratories need to be held to the same standards, so that patients can rely on their diagnostic tests.  For that reason, the regulatory standards should reflect the needs of patients, whose health, well-being, and trust in the FDA will depend on regulatory consistency to ensure accurate diagnostic tests.

We look forward to the opportunity for continued input as these new regulations are planned and implemented.



Jacobs Institute of Women’s Health

Mothers Against Medical Error

National Center for Health Research

National Women’s Health Network

Our Bodies Ourselves

USA Patient Network

Woody Matters