James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved,” by Adam Bonislawski. (Read the full version – subscription required.)

Following is an excerpt:

The clinical lab business exited 2023 much as it entered it, with major questions facing the industry unresolved at the year’s close.

Perhaps most notably, the fate of laboratory-developed tests remains a live issue, though one that the US Food and Drug Administration (FDA) hopes to settle in early 2024. …

The agency issued a proposed rule on LDT oversight at the end of September, putting forth a plan that would amend FDA regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and that all IVDs are medical devices and therefore overseen by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA). The rule calls for a five-stage, four-year phase-out of the agency’s current LDT enforcement discretion policy.

The proposed rule offers carve-outs for certain categories of tests, including what the FDA terms "1976-Type LDTs," which it defines as tests that feature "use of manual techniques (without automation) performed by laboratory personnel with specialized expertise," and human leukocyte antigen (HLA) tests. Otherwise, the proposal was fairly limited in terms of exemptions.

"I didn't parse [the proposed rule] as [FDA] saying it is going to offer flexibility or allow for a lot of exemptions," James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C, told 360Dx following release of the rule.

He said that compared to previous attempts at LDT regulation like the VALID Act and FDA's prior draft guidance on LDTs from 2014, the proposed rule was "basically the strongest approach possible."

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