The FDA’s final rule for laboratory-developed tests (LDTs) imposes a large compliance burden on clinical laboratory operations, a fact which has sparked renewed interest in legislation. However, the rule provides some leniency for LDTs that were already in existence as well as a four-year regulatory run-in that will give labs a significant amount of time to complete regulatory filings for these tests.
The FDA said there is growing evidence that some LDTs do not perform as well as claimed, which may lead to improper selection of therapies for cancers and other diseases. The agency also claimed that LDTs may not perform as well as in vitro
diagnostic kit tests that are reviewed by the agency for the same diagnostic or prognostic purposes. Under the final rule, LDTs that are eligible for grandfathering may not be modified in a significant way unless the test developer submits a new regulatory filing. However, labs will still be subject to requirements for these tests as relates to registration and medical device reporting (MDR) practices.
At one year after the effective date of the final rule, or May 6, 2025, clinical labs that are subject to FDA oversight will have to come into compliance with a subset of Quality System Regulation (QSR) requirements, including requirements for complaint handling procedures and procedures for corrections and removals. After two years, other requirements under the QSR will come into effect, such as those directed toward registration, labeling and investigational use requirements. Three years after the effective date of the final rule, labs will be required to fulfill other, more stringent QSR requirements, such as design controls.
At 3.5 years, labs will be required to file premarket applications for high-risk tests under the PMA program while premarket requirements will come into effect for moderate-risk tests four years after publication of the final rule. A moderate-risk test of a known type will be eligible for review under the 510(k) program while a moderate-risk test for which there is no current legally marketed predicate will have to be filed under the de novo program.
LDTs conducted in labs operated by the Veteran’s Health Administration and the Department of Defense will be granted FDA enforcement discretion, which also applies to tests that are reviewed by the New York State Department of Health. Enforcement discretion is also granted to tests that are used entirely within a specific health care system for unmet needs, but the test must have been ordered by a health care provider who is on staff in that health care system.
The draft version of the rule received more than 6,000 comments, which ranged from outright opposition to complete support. The Advanced Medical Technology Association (AdvaMed) offered support for the final rule, but Scott Whitaker, President and CEO of AdvaMed, reiterated the association’s position on legislation. Whitaker said the rule will help ensure that LDTs are as safe and effective as IVDs that are subject to FDA premarket review, but urged Congress to pass legislation that would significantly restructure the premarket review process.
Congress has attempted on several occasions to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which provides a technology certification process that would streamline the premarket review process used by the FDA. Whitaker said in AdvaMed’s April 29, 2024, statement that the VALID Act would modernize the FDA’s regulatory framework and would support continued innovation in the IVD space.
Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.), authors of the VALID Act, renewed their calls for passage of the legislation in an April 29 statement. DeGette and Bucshon expressed disappointment that the FDA moved ahead with LDT rulemaking, but acknowledged that inaction by Congress’s led to the emergence of the final rule. They called on their fellow members of Congress to “come together and pass our VALID Act.”
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