On May 19, 2026, Representative Neal Dunn, M.D. (FL-2) introduced the Enhancing CLIA Act of 2026, a proposed legislative framework to enhance the regulation of clinical laboratory diagnostics in the United States. This is the first legislative proposal introduced in Congress to address diagnostics regulation since the ACLA v. FDA district court decision vacating FDA’s final rule that would have regulated all laboratory developed testing services (LDTs) as devices under the Federal Food, Drug & Cosmetic Act (FDCA). This proposal takes a markedly different approach than past proposals, such as the VALID Act, which would have established a separate regulatory framework for diagnostics—including both LDTs and in vitro diagnostic (IVD) devices—under FDA’s authority. Instead, the Enhancing CLIA Act would clarify that LDTs are regulated under an enhanced and updated Clinical Laboratory Improvement Amendments (CLIA). At a high level, the Enhancing CLIA Act proposes a framework that would:
- codify the district court ruling in ACLA v. FDA that LDTs are regulated under CLIA and are not devices under the FDCA;
- establish enhanced regulatory requirements for laboratories offering LDTs, including a statutory standard of analytical and clinical validity, required submission of test information to a central database, and mandatory test error reporting; and
- direct CMS to update CLIA with respect to medical specialties, to engage with laboratories and other stakeholders on proposed policy changes, and to periodically update CLIA regulations to ensure they remain current and relevant.
These elements of the bill are detailed further below.
Under the Enhancing CLIA Act, both CLIA and the FDCA would be amended to clarify that LDTs are not medical devices. “Laboratory developed tests” would be defined under CLIA as a type of “examination or procedure” performed in a laboratory, and the definition of “device” under the FDCA would be defined to specifically exclude such LDTs. The definition of “laboratory” under CLIA would be amended to expressly include facilities that examine “patient-specific digital laboratory data,” reflecting that laboratory analyses of such data also are governed by CLIA, i.e., that algorithmic-only analyses performed by laboratories may be LDTs.
Key elements of the LDT definition would include that the test must be (i) developed by a CLIA-certified, high-complexity laboratory, and (ii) performed in the same laboratory or in another laboratory under common ownership and within the same corporate organization as the developing laboratory. LDTs would also include tests developed and performed by CLIA-certified, high-complexity laboratories within a public health network. In contrast, a commercially distributed protocol for use by unaffiliated laboratories would not be an LDT and instead may be a device regulated by FDA.
These amendments would go into effect upon enactment.
Under the bill, CLIA would be amended to include enhanced regulatory requirements for LDTs, which would take effect two years after enactment. Key elements of this framework would include:
- Applicable Standard for LDTs. Under the bill, all LDTs for clinical use would be required to meet an “applicable standard” by having a “reasonable assurance of analytical and clinical validity.” LDTs for investigational use would be subject to a different applicable standard. While premarket review would not be required for LDTs, CMS could prohibit a laboratory from performing an LDT that CMS determined does not meet the applicable standard.
- Supplemental Affirmation that Applicable Standard Is Met. While premarket review of LDTs is not required, LDTs may obtain a “supplemental affirmation” that the applicable standard has been met. There are a number of ways that an LDT could obtain a supplemental affirmation. An LDT would automatically be deemed to have a supplemental affirmation if it is approved by New York State, covered under the MolDx program, or was previously cleared or approved by FDA as a device (prior to enactment). In addition, the Secretary may certify third parties to review LDTs and issue supplemental affirmation. FDA would automatically qualify as a third-party eligible to review LDTs and issue supplemental affirmations.
A supplemental affirmation is not required to market an LDT, but the benefits of having a supplemental affirmation would include: (i) limitations on CMS’s authority to challenge the analytical or clinical validity of the test (as described further below); (ii) equitable treatment to cleared/approved IVDs by CMS for purposes of national coverage determinations (NCDs); and (iii) eligibility to be a companion diagnostic that supports FDA approval of a corresponding therapeutic product.
- CMS Enforcement. If CMS has credible and verifiable information that an LDT for clinical use does not meet the applicable standard for a purpose for which it is offered, then the agency can initiate a process to review the test and, if CMS determines the test does not satisfy the applicable standard, order the test to stop being offered. Under this process for review, CMS may request information from the laboratory, and the laboratory has an opportunity to respond and meet with CMS to address the agency’s concerns. If the test has a supplemental affirmation, CMS cannot initiate this process for purposes covered by the supplemental affirmation.
- Centralized Database of LDTs. The bill would require laboratories to submit key information about LDTs for clinical use to a centralized CMS database. Such information would include, among other things: name and purpose of the LDT, including the analyte(s) measured, relevant disease(s) or impairment(s) assessed, and whether the LDT is intended for screening, diagnosis, prognosis, or other type of assessment; specimen(s) used with the LDT; summary of performance specifications; whether the LDT is a modified version of a cleared/approved IVD; and whether the LDT has a supplemental affirmation. If the test does not have a supplemental affirmation, and it is first offered two years after enactment, then a summary of clinical validity information must also be submitted.
- Test Error Reporting. Laboratories would be required to submit reports to CMS when they become aware that an inaccurate test result from an LDT for clinical use caused serious harm. Reports of death or imminent threats to public health would be required to be reported within five calendar days, and other reports of serious harm would be required quarterly. “Serious harm” includes a misdiagnosis or failure to diagnose that results in the absence, delay, or discontinuation of critical medical treatment, or the administration of unnecessary medical treatment, that causes death or serious injury to the patient.
The bill proposes a two-year transition period during which CMS would be expected to promulgate regulations to implement the new framework. Additionally, during that two-year period, there would be an opportunity for laboratories that already obtained FDA clearance or approval for their test(s) as a device to take steps, as necessary, to maintain such clearance or approval and continue offering the test compliant with FDA device requirements.
The Enhancing CLIA Act would also update the existing CLIA framework, more generally. These updates would include:
- Modernized Specialties for CLIA Certification. CMS would be directed to propose new specialties under CLIA, including to reflect advancements in molecular diagnostics, digital pathology, and next-generation sequencing. CMS would also be required to evaluate whether additional proficiency testing programs should be approved for such specialties.
- Notice of Subregulatory Changes. CMS would be directed to provide advanced notice of proposed subregulatory changes applicable to laboratory regulation, such as new or revised State operations manuals, and allow an opportunity for public comment. Such notice must be provided via a public report at least 90 days prior to the proposed action.
- New Mechanisms to Facilitate Laboratory Engagement with CMS. CMS would be directed to hold regular open door forums with clinical laboratories, no less frequently than annually.
- Regulatory Review. CMS would be directed to review the CLIA regulations at least once every five years and to (i) issue a request for information regarding whether updates are necessary, and (ii) establish a public docket to accept comments on such request.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Medical Devices and Diagnostics practice.
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