FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies
[Editor’s Note: This article has been updated to correct the spelling of Mahnu Davar’s name.]The US Food and Drug Administration has published a final guidance aimed at small entities that produce laboratory-developed tests (LDT). The agency published a final rule in April stating that it will phase out its regulatory discretion for LDTs, and the new guidance only solidifies that position but is much more concise.
On 24 July, FDA published the guidance on what small entities need to know about its oversight of LDTs without the usual opportunity for the industry to first comment on the document in draft form. The final rule was a whopping 160 pages, but the new guide distills that to only 21 pages and provides much of the historical and legal context for its decision to regulate LDTs as it does other in-vitro diagnostics (IVD) (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus 29 April 2024).
“This small entity compliance guide does not introduce new or different enforcement discretion policies from those discussed in the preamble to the LDT Final Rule,” FDA noted in the document. “For several categories of tests, FDA intends to continue the general enforcement discretion approach and generally not enforce any applicable requirements because tests in these categories are, in our experience, unlikely to pose significant risks or are conducted in circumstances that themselves will mitigate the risks.”
As also stated in the final rule, FDA said it will continue not to require premarket applications for certain tests, including those considered 1976-type LDTs, forensic tests, LDTs already approved by the New York State Department of Health’s Clinical Laboratory Evaluation Program (NYS CLEP), and certain LDTs for unmet needs. The agency also emphasized its phaseout policy for IVDs certified under the Clinical Laboratory Improvement Amendments (CLIA) that meet certain regulatory requirements and don’t meet its traditional definition of an LDT.
“FDA adopted this scope because it recognizes that not all laboratories have understood the limited nature of FDA’s general enforcement discretion approach and have been offering IVDs based on the approach even when those IVDs do not fit what FDA generally considers to be an LDT,” the agency added.
The guidance details the risk-based phase-out for LDTs and the timeline for different test makers to provide the agency with information on their tests and submit premarket applications.
Mahnu Davar, a partner at Arnold & Porter, said the guidance raises the same question as did the rule: whether FDA has the authority to regulate LDTs in the way it has argued it does.
"FDA will say that this is part of its public health mission to help labs come into compliance and this is a very clear statement of compliance,” he told Focus. “This is also one step further for FDA to firm up its ground if it chooses to in the coming year to inspect or take enforcement [actions].”
Davar said that he is not surprised by the guidance, which is another normal step that the agency takes whenever it implements a new regulatory regime. Furthermore, he added that it shows how serious the agency is about enforcing its LDT rule, which is being challenged by the laboratory industry.
Final guidance
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