Skip to main content
Premium Trial:

Request an Annual Quote

ACLA Expresses Concern Over FDA's Proposal for Regulating In Vitro Diagnostic Tests

NEW YORK (360Dx) – In a letter to members of Congress, the American Clinical Laboratory Association expressed strong objection to the US Food and Drug Administration's recent proposal for regulating in vitro clinical tests via regulation.

The FDA Technical Assistance document, submitted to US Reps. Larry Bucshon, R-Ind., and Diana DeGette D-Colo., earlier this month, proposed new legislative language for the Diagnostic Accuracy and Innovation Act (DAIA) that departed significantly from the framework that Bucshon and DeGette had originally drafted with input from industry stakeholders.

"The March 21, 2017 DAIA Discussion Draft, not the FDA TA, should remain the starting point from which congressional and stakeholder discussions occur as we move forward to develop an appropriate regulatory framework for in vitro clinical tests," ACLA President Julie Khani wrote in a 23-page letter to the legislators dated Aug. 20.

Khani noted that the FDA TA proposes a "distinctly different framework" than the original DAIA discussion draft.

In the letter, ACLA strongly objected to the FDA's assertion that it has jurisdiction to regulate laboratory developed tests (LDTs).

"ACLA has repeatedly asserted, and continues to assert now, that laboratory-developed tests are not devices, and therefore FDA has no authority with respect to LDTs under current law that would be 'retained' under any new framework," Khani wrote in the letter.

ACLA maintained that in vitro clinical tests (IVCTs), which include LDTs, should be governed by their own regulatory framework, distinct from devices, the letter stated.

The FDA position, ACLA asserted, "does not account for the distinct role [the Centers for Medicare & Medicaid Services] plays in the regulation of laboratory operations." While the DAIA discussion draft more clearly delineated differences in jurisdiction between the FDA and CMS, the FDA's proposal is more murky in this area, and the agency's recent technical assistance document would give the FDA "virtually unfettered discretion" to regulate LDTs when it deems its involvement is necessary for protecting public health, according to the letter.

ACLA also objected to the FDA's proposal that the agency can implement oversight provisions through guidance rather than regulation. Implementation by guidance is "unacceptable" because it "bypasses the Administrative Procedure Act's well-established notice-and-comment procedures, and fails to account for an economic impact analysis," the ACLA letter stated.

Other FDA proposals that ACLA took issue with include a transition provision that ACLA asserted could subject IVCTs to regulation "immediately after enactment," and a grandfathering provision that ACLA claimed "permits FDA to 'claw back' grandfathered tests at its discretion without basis in meaningful standards."

In addition, ACLA said the FDA's proposed risk classification is confusing and unclear, and raised concerns that the FDA's proposal to eliminate the moderate-risk category for IVCTs could lead to the FDA classifying more tests as high risk.

ACLA suggested that any review of modifications to already marketed tests, including grandfathered tests, should be limited to modifications that have "meaningful clinical impact or significantly modify the test's intended use." The FDA's approach would require premarket submission for a wider set of conditions than anticipated by DAIA, the lab association letter stated.

The FDA's definitions of analytical validity and clinical validity in approval standards also could grant the agency "unprecedented discretion" in determining whether an IVCT is analytically or clinically valid, Khani wrote.

Separately, in its own letter to the legislators also submitted on Aug. 20, Pew Charitable Trusts, took an alternative view of the FDA framework, stating that the FDA's proposal "contains many important elements essential to protecting patients and consumers."

"The [FDA] proposal would subject diagnostic tests to the same regulatory regime regardless of where they are assembled, and would establish regulatory requirements based on a test's risk," the Pew letter stated.