The U.S. Food and Drug Administration (FDA) is taking definitive steps to reinforce regulations surrounding laboratory-developed tests (LDTs). On September 29, 2023, the FDA announced its Proposed Rule seeking to clarify within its regulations that LDTs qualify as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA has set its sights on April 2024 for the release of the Final Rule, as indicated by the Agenda of Regulatory and Deregulatory Actions. This expedited timeline underscores the FDA’s commitment to LDT oversight.

Adding to the momentum, a joint statement was issued by the FDA and CMS on January 18, 2024, titled “FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made.” This statement reinforces the agencies’ collective determination to regulate LDTs as medical devices. Their resolve stands firm amid significant resistance from industry stakeholders and the influx of 6,000+ public comments in response to the Proposed Rule.

FDA Continues to Signal Its Intent to Regulate LDTs

The joint statement issued by the FDA and the Centers for Medicare and Medicaid Services (CMS) underscores the FDA’s position that regulation of LDTs is necessary, stating in part:

• “While the U.S Food and Drug Administration (FDA) actively oversees tests made outside laboratories by test manufacturers, . . . LDTs . . . are often used without such oversight. The FDA’s approach was developed half a century ago when tests made and used in single labs were generally simple, often made to address local individual needs, and mostly manufactured in small volumes. . .”
• In recent decades, the FDA has identified concerns with a number of LDTs. For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases.”

It’s clear that the FDA believes that oversight of LDTs is necessary to protect public health. While April 2024 is the anticipated date for the Final Rule, it is important to note that the FDA is not legally bound to adhere to this timeline. However, the FDA’s firm stance and proactive steps thus far indicate a strong likelihood of follow-through.