Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn strong backlash, with trade groups opposing the proposal and more than 1,400 individuals and organizations submitting comments to date.
The FDA has published the proposed rule in late September, announcing plans to update the regulations to make it explicit that IVDs are regulated as devices regardless of whether the manufacturer is a laboratory. As part of the proposal, the FDA indicated its intention to phase out its current blanket discretion approach to LDT enforcement and thereby provide greater testing oversight.
AdvaMed, a trade group representing the medical technology industry, published A declaration the day the FDA published the proposed rule. The trade group was a supporter of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have created a new regulatory framework for diagnostics, although it failed to gain congressional authorization. In its statement, AdvaMed said it is evaluating the FDA’s proposed rule and supports establishing a “modernized, diagnostics-specific, risk-based regulatory framework for all in vitro clinical tests, regardless of regardless of where they are developed and overseen by the FDA. »
Zach Rothstein, executive director of the group’s diagnostic wing, AdvaMedDx, later said 360Dx that the industry organization remains focused on VALID because many of the key elements it likes in the law, “like technology certification and the operation of the risk-based approach, would require an act of Congress.”
The American Clinical Laboratory Association (ACLA) also wants Congress to find a solution for LDTs. The day the FDA released the proposed rule, the trade group said it planned to urge the FDA to withdraw its proposal and resume work toward legislation providing a framework for LDTs.
AdvaMed and other organizations have the opportunity to submit formal comments on the FDA’s proposed rule. So far, the FDA has received more than 1,400 comments, but few comments from industry groups, who still have time to submit comments.
The American Association of Bioanalysts and the National Independent Laboratory Association are among the groups submitting comments. However, the commentwhich was sent within two weeks of the rule’s publication, only requests an extension of the comment period so that the organization can give “substantial comments that reflect the views of stakeholders, ensuring that final versions of these rules are fit for purpose.”
Several individual members of the “laboratory medicine community” have since submitted requests for a 60-day extension of the comment period. The queries functionality the same text which states that more time is needed to prevent the imposition of requirements “unfamiliar to most laboratories” from having “unintended consequences.” The FDA has said that it will meet the original deadline for comments.
The alternative medicine industry also rallied together to flood the FDA with similar comments critical of the proposed LDT regulations. The Natural Health Alliance of the United States provided a pre-populated form to allow people to comment on the proposed rule; a large number of comments submitted to date copy the text exactly. The comments accuse the FDA of trying to “impose unnecessary regulations on LDTs.”
Representatives of clinical laboratories and test developers may have other concerns, with the proposal raising questions about how the FDA will cope with the burden of LDT oversight and fail to create the new regulatory framework outlined in the law VALID. A more complete picture of attitudes toward the proposed rule will emerge as more organizations submit comments before the Dec. 4 deadline.
