Late in the previous year, the American Clinical Laboratory Association (ACLA) presented comprehensive feedback to the U.S. Food & Drug Administration (FDA), opposing its proposed rule to categorize laboratory developed tests (LDTs) as medical devices for regulatory purposes under the Federal Food, Drug, and Cosmetic Act. Despite the Centers for Medicare & Medicaid Services (CMS) now endorsing the proposal, ACLA has remained steadfast in its stance.
Susan Van Meter, President at American Clinical Laboratory Association, voiced her organization's concerns. "We firmly maintain that LDTs are not medical devices and regulating them as such would be harmful to patients and would severely hamper innovation in the next generation of diagnostics," she said. Van Meter further elaborated on how these tests contribute to healthcare, stating, "Every day, LDTs help physicians and patients to diagnose diseases and make informed health care choices." She concluded by suggesting a collaborative approach towards regulation: "Rather than imposing a device framework that is inappropriate for LDTs, ACLA encourages FDA to work with Congress, ACLA, and other stakeholders to develop legislation that would establish a role for FDA in the regulation of LDTs aligned with their already robust oversight."
In a press release jointly issued by FDA and CMS in October, it was reported that the FDA had proposed a rulemaking notice aimed at ensuring LDTs' safety and effectiveness by phasing out the agency’s current approach towards these tests. If this proposed rule becomes final, most LDTs would be subjected to an enforcement approach similar to other tests.
The same press release highlighted that while FDA stringently oversees tests manufactured outside laboratories, LDTs have not received as much scrutiny. This approach was developed about 50 years ago when tests were created and used within single labs for local individual needs. As such, "the FDA generally did not enforce requirements for LDTs," explained the agency. However, LDTs have since evolved, and there are now increased safety concerns. These include potential issues with LDTs that could lead to patients being over- or under-treated, inappropriate therapies being prescribed, and incorrect diagnoses being made.
