The AAMC submitted comments on Dec. 5, to the U.S. Food and Drug Administration (FDA) related to the agency’s September 29 proposed rule updating the definition of laboratory developed tests (LDTs)/in vitro diagnostic products (IVDs) as “devices under the [Federal Food, Drug, and Cosmetic] FD&C Act including when the manufacturer of the IVD is a laboratory.” The agency has proposed that this change would explicitly codify the agency’s longstanding claim that “LDTs are devices under the FD&C Act and would reflect the fact that the device definition in the FD&C Act does not differentiate between entities manufacturing the device.” In addition to the proposed rule, the FDA proposed an enforcement policy, which would result in the agency’s review and oversight of all LDTs over four years.
In its comment letter, the AAMC detailed the unique role of academic medical centers in LDT development and their use in direct patient care. The letter also emphasized that the AAMC shared the FDA’s goal of ensuring “that LDTs provide accurate, timely diagnostic information so that providers, with patients and their families, can best determine a course of treatment. … That is precisely the goal, the mandate, and the experience of the academic medical centers that have successfully developed LDTs for years to guide decisions about treatment plans.”
However, the AAMC also stressed its concern that the FDA’s proposed new enforcement policy “would have an immediate and detrimental effect on the ability of academic medical centers to provide specialized and patient-centric medical care,” and urged the agency to “maintain its enforcement discretion for tests that are developed in the highly regulated, specialized academic medical center environments to allow the agency to focus on those tests being marketed directly to patients without the safeguards and oversight already fundamental for LDTs at academic medical centers.”