Since the release of a 2014 draft guidance from the FDA, the lab community has reeled from a potential change in regulatory oversight. Laboratory-developed tests (LDTs) are considered medical devices in many instances by the FDA, but the FDA issued enforcement discretion awaiting clear regulatory direction from Congress. In the past two years, Congress has been unable to specify whether it prefers traditional regulation by CMS under the Clinical Laboratory Improvement Amendments (CLIA) or direct regulation by the FDA, despite legislation having been introduced on both sides of the argument, including the VALID Act, resulting in the FDA issuing a proposed rule.

FDA LDT Rule

Despite the multiple attempts to regulate LDTs, including most recently through the VALID Act, Congress has failed to pass reform. As a result of this, the FDA released its proposed rule on September 29, 2023 “to make explicit that laboratory-developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetics Act.” Since the release of the proposed rule, LAB has taken many steps to react and express opposition to the rule:

• LAB held both a steering call with members and an allied organizations call to review the rule.

• LAB submitted comments on the rule and incorporated steering member feedback urging the FDA that Congress is the sole body that can grant FDA direct authority over LDTs and withdraw the proposed rule.

• LAB introduced an amendment to prevent the FDA from using funds to finalize the regulation of LDTs as medical devices.

We will remain engaged on the topic and will shift to focus on what the rule means from a compliance standpoint, as well as purse alternative options, including CLIA modernization.

VALID Act

The LAB Coalition remains very concerned about the disruption the VALID Act could cause the lab industry, particularly with regards to access, costs, and innovation. We sent a letter in May 2022 to the Senate HELP Committee pushing instead for a more gradual change to laboratory oversight through a pilot program, to ensure this is done right.

LAB Coalition also joined other stakeholders in sending a letter to Senate leaders opposing the VALID Act.

FDA Laboratory Certification Pilot Program

• Establishes 5-year pilot program at Center for Devices and Radiological Health (CDRH)

• Voluntary laboratory certification based on requirements of New York State

• Focuses on test developer, not test itself

• Participating labs demonstrate processes for analytic and clinical validity

• Tests developed under scope of waiver are authorized by FDA

• New high-risk tests and modifications to high-risk tests must be reviewed by FDA

• FDA can place holds on tests and require their withdrawal from use

• Participating labs submit annual report

• FDA must develop certification framework through public meeting and stakeholder input

This proposal would be offered as an alternative to the VALID Act

Gives FDA and labs time to learn new process before making permanent policy

Modeled after current processes under New York system