Jonathan Genzen, left, and Jonathan Carr are sitting in chairs while talking to each other.

Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD, chief compliance officer, discuss the FDA’s final rule on LDTs.

May 28, 2024

ARUP Laboratories’ latest webinar on the FDA’s final rule to regulate laboratory-developed tests (LDTs), which will dramatically shift how clinical laboratories can develop and offer LDTs, is now available on ARUP’s website.

Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD, chief compliance officer, discussed the rule’s requirements and how these requirements differ across certain settings and types of testing in the May 23 session.

“We are committed to supporting our clients and patients with a diverse testing menu that continues to innovate and to helping them navigate these regulatory changes,” Genzen said.

He opened the hour-long webinar summarizing the rule, which makes it explicit that in vitro diagnostics (IVDs) that are manufactured by clinical laboratories—i.e., LDTs—are considered devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Rather than creating a definition of LDTs, the FDA added 10 words, bolded below, to the regulatory definition of IVD products.

In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) (1) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.

Genzen spent much of the webinar explaining how the FDA will phase out its general enforcement discretion approach for LDTs so that new IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. He also offered a more extensive analysis, providing examples of the types of IVDs that will remain subject to enforcement discretion. Those IVDs include 1976-type LDTs, some human leukocyte antigen tests for transplants, forensic tests, tests performed by the Veterans Health Administration and the Department of Defense, and public health surveillance tests.

After the presentation, Jonathan Carr, JD, ARUP’s chief compliance officer, joined Genzen and moderated the question-and-answer segment of the webinar, which included questions about innovation and unmet needs.

The FDA has stated that “LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare facility” would fall under the enforcement discretion policy. Genzen said the rule does not accurately reflect the current structure of healthcare systems and laboratory testing, as many healthcare facilities have affiliated hospitals that might be under separate ownership, and laboratory directors at most academic medical centers may not be employees of the hospital. He added that he hopes the FDA will clarify expectations so that unmet needs can be fully addressed, regardless of setting.

“None of this is in the rule itself. It’s in the FDA’s description of enforcement discretion. These requirements could change because they’re not actually codified, which is disconcerting,” Genzen said.

Genzen closed the webinar with a promise to keep ARUP clients and the laboratory community updated and informed with additional webinars and other resources throughout the implementation process.

“There is going to be a lot of frustration [felt] by clinical laboratories because we don’t have an easy path ahead of us. I do think we can accomplish positive change if we continue to work together,” Genzen said.

Watch the webinar and view ARUP’s informational resources here.


Bonnie Stray,