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Regulatory Focus — FDA proposes down-classifying most high-risk IVDs

Regulatory Focus — FDA proposes down-classifying most high-risk IVDs

The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices. The agency says the move will ease the burden on IVD sponsors who can use the 510(k) premarket notification pathway instead of the more burdensome premarket approval (PMA) process.

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), announced the proposal in a statement on 31 January, in which he also stated that most of the affected tests are for infectious disease and companion diagnostic IVDs.

“CDRH would still be conducting a premarket review of reclassified tests under the 510(k) pathway,” he added. “Such reclassifications may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests.”

In September 2023, FDA’s Microbiology Devices Panel held a meeting where they recommended down-classifying three types of infectious disease IVDs that Shuren noted would be a starting point for CDRH’s reclassification plan. The tests include nucleic acid and serology-based IVDs to diagnose Hepatitis B infections, serology-based IVDs to detect human parvovirus B19, and cell-mediated immune reactivity IVDs to help detect peptide antigens that are associated with Mycobacterium TB infections.

Shuren told Focus during a 1 February meeting on the future of diagnostics hosted by Friends of Cancer Research that CDRH’s Office of Health Technology 7: Office of In Vitro Diagnostics (OHT7) is already combing through a list of IVDs to reclassify. Besides the three types of IVDs mentioned, he said the center has many more IVDs in mind to reclassify and will announce them when the agency starts the reclassification process.

“The three we listed is because that’s already public, but we have many more on the list,” said Shuren. “We’re going to go through that process, and we’re going to announce [the list] as we kick off the process, but the [Fluorescence in situ hybridization (FISH)] test would be one [of the tests likely to be on the list.]”

FISH tests are used to map a person’s genetic material and are used to diagnose a range of cancer types including breast cancer, multiple myeloma, lymphoma, and leukemia.

Shuren emphasized this kind of reclassification isn’t something new for CDRH, and it has periodically looked at products to determine if there was enough evidence to warrant reclassification based on the available data. He noted that the center looked into reclassifying products as part of its 2014-2015 Strategic Priorities and has reclassified certain Hepatitis C Virus Antibody Tests and Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests from class III to II.

The reclassification proposal comes amid FDA’s efforts to finalize a rule that would phase out its enforcement discretion of laboratory-developed tests (LDTs). While Shuren and other top FDA officials would prefer Congress to pass legislation to reform diagnostics in general, lawmakers have yet to pass legislation that would reform LDT oversight. (RELATED: Experts expect opponents of LDT rule to ramp up Congressional lobbyingRegulatory Focus 14 December 2023)

“[The reclassification proposal] has implications for all test developers of high-risk tests, whether they are made by a non-laboratory or laboratory,” Shuren told Focus. “We are laying out that in the future, when we’ve completed that process, we’ll have tests now being overseen through the 510(k) program rather than the PMA program.”

For new tests that come to FDA for premarket review, Shuren said the agency will continue to take a risk-based approach when initially classifying the IVD to determine whether it may be classified into class II through De novo classification and special controls, instead of being considered a class III device that requires going through the PMA pathway.

“Based on our experience, we believe that special controls could be developed, along with general controls, that could provide a reasonable assurance of safety and effectiveness for most future companion diagnostic and infectious disease IVDs,” he said in the agency statement. “As such, they would be regulated as class II devices.”