American Clinical Laboratory Association v.
U.S. Food and Drug Administration

Tina Papagiannopoulos*

Why It Made the List

The regulation of laboratory-developed tests (LDTs) has been one of the most contested and consequential issues in food and drug law for decades. On March 31, 2025, Judge Sean Jordan of the U.S. District Court for the Eastern District of Texas issued a much-anticipated opinion in ACLA et al. v. FDA,[1] which vacated the Food and Drug Administration’s (FDA’s) May 6, 2024 final rule that sought to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).[2] The decision has sweeping implications for the clinical laboratory industry, for the patients and physicians who depend on laboratory-developed testing services, and for the broader question of how far FDA’s regulatory authority extends in the post-Loper Bright era.[3] This chapter summarizes the court’s opinion, discusses the arguments raised by the parties, and considers the potential impact of the decision on the future of LDT regulation.

Background

Historical Regulatory Framework

The regulatory status of LDTs has long been shaped by two overlapping federal regimes: the FDCA, which governs medical devices regulated by FDA, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which establishes quality standards for clinical laboratories administered by the Centers for Medicare & Medicaid Services (CMS). Under CLIA, all laboratories that perform clinical tests on human specimens must be certified by CMS or accredited through CMS-approved accreditation organizations.[4] Both CMS and the accreditation organizations issue standards to ensure that laboratory performance is “consistent” and that their tests are “valid and reliable,” including quality-control standards and standards for the qualifications of personnel supervising and performing the tests.[5] Laboratories that develop and perform high-complexity tests must be overseen by a laboratory director who is either a licensed physician or holds a doctoral degree in a relevant science.[6] CLIA further requires strict quality controls, proficiency testing multiple times a year, and regular inspections by the Department of Health and Human Services (HHS), state agencies, and/or authorized accrediting bodies.[7] Laboratory-developed tests have often been responsible for scientific innovations and breakthroughs—for example, testing for the BRCA1/BRCA2 genetic mutations that indicate susceptibility to breast and ovarian cancer—that have become part of the standard of care and, in some cases, have been incorporated into FDA-cleared or approved IVD test kits.[8]

The Medical Device Amendments of 1976 created a comprehensive framework for regulating medical devices under the FDCA, including premarket review, classification into risk-based categories, and post-market controls.[9] However, when FDA began implementing that framework, the agency exercised enforcement discretion with respect to most laboratory-developed tests.[10] At the time, LDTs were typically developed and used within a single hospital laboratory, produced in small volumes, and performed using manual techniques by specialized laboratory personnel.[11] Over time, however, the nature of LDTs changed significantly. Advances in molecular diagnostics, genomics, and automated laboratory instrumentation led to the development of increasingly complex tests performed at scale and marketed nationwide through centralized laboratory networks.[12]

Over the years, FDA from time to time attempted to exercise oversight over certain LDTs, but it generally has not enforced medical device requirements with respect to most LDTs. According to FDA, the agency intended for its enforcement discretion to extend only to LDTs as traditionally defined by the agency, i.e. an in vitro diagnostic (IVD) that is intended for clinical use and that is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory requirements under CLIA to perform high complexity testing.[13] During this extended period of general FDA enforcement discretion, however, IVDs were offered commercially by laboratories as LDTs, even if they were not designed, manufactured, and used within a single laboratory. FDA referred to such tests in the final rule as “IVDs offered as LDTs.”[14] In light of this regulatory history, LDTs have been regulated primarily by CMS at the federal level and by state laboratory regulatory bodies.

FDA’s Rationale for the 2024 Final Rule

After decades of enforcement discretion, FDA published a final rule on May 6, 2024, announcing its intent to treat all laboratory-developed tests (including IVDs offered as LDTs) as medical devices and to regulate them under the FDCA.[15] Specifically, FDA amended the regulatory definition of “in vitro diagnostic products” in 21 C.F.R. § 809.3(a), which specifies that IVD products are devices, to add the language “including when the manufacturer of these products is a laboratory.”[16] The rule established a phased enforcement approach over four years, with reporting, registration, and labeling mandates beginning in years one and two, and enforcement of premarket review requirements beginning in years three and four.[17] At the same time, the final rule created a series of non-binding enforcement discretion carveouts for certain categories of tests, including existing tests (with limited modifications), tests approved by the New York State Department of Health’s Clinical Laboratory Evaluation Program, tests manufactured and performed within a healthcare system to meet an unmet need, and “1976-Type LDTs.”[18]

FDA explained that the rule was intended to address what it viewed as a growing regulatory gap between laboratory-manufactured tests and other commercially distributed diagnostic devices.[19] The agency emphasized that modern LDTs increasingly rely on complex technologies such as high-throughput sequencing, advanced bioinformatics, and automated instrumentation and are often marketed nationally through centralized laboratory networks rather than confined to a single hospital laboratory.[20] FDA also cited public health concerns, including the possibility that inaccurate or unreliable tests could lead to missed diagnoses, inappropriate treatment decisions, or delayed care.[21]

FDA acknowledged that the costs of the rule would be significant, projecting total costs over the next two decades ranging from $12.57 billion to $78.99 billion, with compliance costs for laboratories exceeding $1 billion per year.[22] The agency conceded that the “increased cost to laboratories” might cause price increases and “reduce the amount of revenue a laboratory can invest in creating and/or modifying” tests.[23] FDA estimated that the rule would initially affect about 79,114 existing tests offered by 1,181 laboratories, and approximately 10,013 new tests every year going forward.[24]

The Parties and Procedural History

The plaintiffs in this consolidated litigation included the American Clinical Laboratory Association (ACLA), a national trade association that represents the clinical laboratory sector; the Association for Molecular Pathology (AMP), a professional society in the field of molecular pathology; infectious disease laboratories HealthTrackRX Indiana, Inc. and HealthTrackRX, Inc.; and Michael Laposata, M.D., a medical doctor and clinical pathologist.[25] ACLA’s members include laboratory services providers such as Quest Diagnostics, Labcorp, Mayo Clinic Laboratories, and ARUP Laboratories.[26]

The ACLA plaintiffs filed suit on May 29, 2024, and AMP filed its complaint in the Southern District of Texas on August 19, 2024, which was subsequently transferred to the Eastern District of Texas and consolidated with the ACLA case.[27] ACLA moved for summary judgment on September 3, 2024, and AMP moved for summary judgment on September 27, 2024.[28] FDA filed a cross-motion for summary judgment and opposition brief on October 25, 2024.[29] The court granted the plaintiffs’ motions and denied FDA’s motion for summary judgment.

Summary and Discussion

The core dispute centered on a seemingly simple question that carried enormous consequences: Are laboratory-developed tests “devices” within the meaning of the FDCA? The plaintiffs argued that LDTs are professional services performed by highly trained laboratory scientists and are not tangible, manufactured products that can be regulated as “devices.”[30] FDA countered that the physical components used to perform laboratory tests—”reagents, instruments, and other articles” that “function together to produce a test result”—constitute “IVD test systems” that are unambiguously “devices” as Congress defined that term, regardless of whether they are manufactured by a laboratory or a non-laboratory manufacturer.[31]

LDTs as Services

As a threshold matter, the court defined “laboratory-developed test services” as in-house diagnostic tests “developed, validated, and performed by trained professionals within a single clinical laboratory.”[32] According to the court, the tests are “performed on blood, urine, tissue, or other types of specimens at the request of an individual physician, in the context of a specific doctor-patient relationship.”[33] Treating doctors rely on such tests “for patient diagnosis, care, and treatment, ranging from routine tests such as pap smears and gram stains, to sophisticated molecular and genetic sequencing tests for cancer, heart disease, and rare and infectious diseases.”[34] The court notably framed LDTs as “services,” which dovetailed neatly into its analysis of whether LDTs could be a “device” under the FDCA. The court, however, did not elaborate on the “single clinical laboratory” prong of its definition and did not explain how its decision would be affected if a test was developed by more than one entity.

The Definition of “Device”

Central to the court’s analysis was the definition of “device” in Section 201(h) of the FDCA, which provides, in relevant part, that a device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory.”[35] The court considered the “ordinary, contemporary, common meaning” of these operative terms and applied canons of statutory construction to conclude that “device” refers to tangible, physical products—not professional services.[36] As the court explained, all the terms used in the definition—“instrument,” “apparatus,” “implement,” “machine,” “contrivance,” “implant,” and “in vitro reagent”—refer to tangible, physical objects.[37] The catchall term in the definition “article” likewise “denote[s] ‘material things’” rather than intangible services, a reading confirmed by decades of case law, according to the court.[38]

The court rejected FDA’s attempt to characterize the collection of physical tools that laboratory professionals use to perform a test as an “IVD test system” that itself constitutes a “device.”[39] To illustrate the problem with FDA’s reasoning, the court offered a series of analogies. “When a radiologist reads an x-ray, he or she is providing a service that depends on a medical device—the x-ray machine. But the radiologist is rendering a service and is not subject to regulation under the FDCA.”[40] Similarly, “when a heart surgeon conducts an operation to repair a valve or insert a pacemaker, the surgical procedure does not become a ‘device’ merely because it involves the use of surgical instruments, sutures, and other medical equipment.”[41] Under FDA’s reading, the court reasoned, nearly every medical procedure or examination would constitute “manufacturing” a medical “device,” thereby implicating limitless FDA oversight.[42]

The court also criticized FDA’s self-created term “IVD test system” and related definitions as “affirmatively work[ing] against the FDCA’s limits on FDA’s jurisdiction” by improperly conflating two distinct things: “(1) a discrete set of tangible articles packaged as a product for commercial distribution (e.g., a COVID-19 test kit), and (2) an assortment of physical tools that laboratory professionals use in transient relationships to each other to deliver a service.”[43] The court emphasized that agencies “can’t evade established rules of statutory construction by fabricating their own definitions of commonly used terms, untethered to their ordinary meaning . . . .”[44]

The Broader Statutory Framework: FDCA and CLIA

Beyond the plain text of the device definition, the court found that its interpretation was reinforced by the broader statutory framework, including CLIA.[45] The court observed that the sequence of legislative enactments—the FDCA in 1938, the Clinical Laboratories Improvement Act in 1967, the Medical Device Amendments (MDA) in 1976, and the Clinical Laboratory Improvement Amendments in 1988—“reflects that Congress viewed (1) ensuring medical-device safety and effectiveness, and (2) ensuring laboratory-testing accuracy, as distinct problems requiring different regulatory solutions.”[46] Despite this alternating sequence, “Congress never indicated that there was any overlap between these regulatory schemes.”[47] On the contrary, “the Senate Report on the 1967 CLIA bill addressed concerns about possible overlap between regulation of clinical laboratories under CLIA and under the Medicare statute, but it did not mention any role for the FDCA in regulating clinical laboratories.”[48] Similarly, the House Report on the 1988 CLIA bill “described ‘[t]he Current Regulatory System’ as involving federal regulation of laboratories ‘under two programs’—the Clinical Laboratories Improvement Act of 1967 and the Medicare statute—and did not mention regulation under the FDCA.”[49] The Report also stated that CLIA’s purpose was to ensure that laboratory test services are governed by a single “unified regulatory mechanism.”[50]

The court reasoned that if, as FDA asserted, Congress intended the MDA to subject laboratory-developed test services to the FDCA’s device regime, then “the enactment of the CLIA Amendments in 1988 makes little sense.”[51] Under FDA’s theory, by 1988, FDA already had authority to regulate those same tests—”authority that it was simply declining in its discretion to exercise.”[52] That theory, the court concluded, “cannot be sustained without rendering CLIA largely, if not entirely, pointless.”[53]

FDA’s Historical Posture Toward LDTs

The court traced FDA’s shifting posture towards regulating laboratory-developed tests over several decades, pointing to inconsistencies between the agency’s assertions of jurisdiction and concurrent legislative history.[54] For well over a decade following Congress’s enactment of the MDA in 1976 through 1992, “FDA did not claim any authority to regulate laboratory test services as ‘devices.’”[55] FDA first suggested it might possess such authority in 1992 in a draft Compliance Policy Guide, but the laboratory profession immediately objected, and FDA declined to finalize the guidance, assuring laboratories that it did “not intend to routinely exercise its authority over home-brew tests.”[56] The agency subsequently made tentative claims of jurisdiction in the preamble to a 1996 proposed rule and the 1997 final rule regarding analyte-specific reagents, but each time continued to exercise enforcement discretion rather than actively regulating LDTs.[57]

FDA changed course again in June 2010, suggesting that it was “reconsider[ing] its policy of enforcement discretion” for laboratory-developed test services, and the agency issued draft guidance in 2014 proposing to phase in the regulation of LDTs over nine years.[58] In 2016, the House Appropriations Committee directed FDA to “suspend further efforts to finalize” its guidance and to “continue working with Congress to pass legislation that addresses a new pathway for regulation of [LDTs] in a transparent manner.”[59] FDA summarized the comments it received on the 2014 draft guidance in a January 2017 discussion paper and explained that the agency would not be finalizing its guidance at that time “to allow for further public discussion . . . and to give our congressional authorizing committees the opportunity to develop a legislative solution.”[60] In 2020, HHS’s Office of General Counsel issued a memorandum (the “Charrow Memo”) questioning whether FDA had authority to regulate LDTs as devices, observing that LDTs are not “goods or commodities” but rather “clinical laboratory services.”[61] Congress, meanwhile, considered but declined to enact several pieces of legislation that would have reshaped the regulatory framework, including the VALID Act and the VITAL Act, neither of which passed in any session.[62]

The Laboratory Plaintiffs argued that FDA’s reliance upon a “long-extant statute” to bring about a “transformative expansion in [its] regulatory authority” that “Congress ha[d] conspicuously and repeatedly declined to enact itself” violated the major questions doctrine, which “requires agencies to point to ‘clear congressional authorization’ for actions of major ‘economic and political significance.’”[63] They argued that if Congress had intended to “upend the whole clinical laboratory profession,” it “would have used the appropriate terminology to denote that intent and not hidden it in a statute expressly targeted” at manufactured products.[64]

FDA’s Arguments in Defense of the Final Rule

FDA mounted a vigorous defense of its statutory authority. The government argued that the plain text of the FDCA “unambiguously” covers IVD test systems made by laboratories as “devices,” emphasizing that the statute has always defined “device” broadly to include any diagnostic “instrument,” “apparatus,” or “contrivance,” together with their “components, parts, and accessories.”[65] FDA contended that the fact that an IVD test system is made by a laboratory, or that a laboratory monetizes tests on a fee-for-service basis, does not change the fact that the test system itself is comprised of physical components that function together to produce a test result.[66] The government also argued that CLIA and the FDCA “complement rather than conflict with each other,” noting that “regulation under CLIA addresses the proficiency with which laboratories perform tests rather than design them,” while “regulation under the FDCA addresses the design of test systems to help ensure that their results are clinically valid.”[67]

On the major questions doctrine, FDA argued that this was an “ordinary case of federal regulation pursuant to unambiguous Congressional authorization,” not “an extraordinary one presenting major political, economic, or federalism questions.”[68] FDA further contended that it had not “newly uncover[ed]” jurisdiction over laboratory-made IVD test systems but had claimed this authority continuously since 1977.[69]

The Court’s Ruling

The court rejected FDA’s arguments across the board. It found that FDA’s expansion of its jurisdiction was “foreclosed by the text, structure, and history of the FDCA and CLIA.”[70] The court held that Congress created two separate regulatory frameworks: one vesting authority to regulate tangible devices with FDA, and another vesting authority to regulate laboratory services with CMS.[71] Because the court resolved the case on the ground that the final rule exceeded FDA’s statutory authority, it did not need to address the Laboratory Plaintiffs’ additional claim that the rule was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”[72] The court likewise declined to reach the major questions doctrine, finding that the FDCA’s “plain text” was sufficient to resolve the dispute.[73] However, the court acknowledged the doctrine’s relevance, observing that it counsels that a “decision of such magnitude and consequence on a matter of earnest and profound debate across the country must rest with Congress itself, or an agency acting pursuant to a clear delegation from that representative body.”[74]

Criminal Law Implications

The court also highlighted what it described as the “troublesome” and “implausible” consequences of FDA’s interpretation.[75] Because FDCA violations can carry criminal penalties, including felony offenses with penalties of years of imprisonment, accepting FDA’s reading would mean that “tens of thousands of professionals across the country performing millions of diagnostic testing services every year, working with thousands of doctors and patients, have done so for decades in open and direct violation of the law.”[76] According to the court, FDA’s theory would mean “that the entire clinical laboratory sector, a significant part of the healthcare system, has been breaking the law for nearly fifty years, and possibly much longer,” with its “only protection coming from a policy of enforcement discretion that FDA maintains it is free to revoke at any time.”[77]

While the Laboratory Plaintiffs argued that the rule of lenity should be applied given the threat of criminal penalties, the court disagreed, finding the rule inapplicable because there is no “grievous ambiguity” in the statute.[78] Nevertheless, the court noted that “the fallout” from FDA’s interpretation “underscores [its] implausibility,” and affirms that the agency’s “strained reading of the FDCA flouts, rather than effectuates, Congress’s intent.”[79]

The Remedy

Having concluded that the final rule exceeded FDA’s authority, the court turned to the appropriate remedy. Citing binding Fifth Circuit precedent, the court held that “vacatur under § 706 of the Administrative Procedure Act is . . . the ‘default’ remedy for unlawful agency action” and that “setting aside agency action under § 706 has nationwide effect, is not party-restricted, and affects persons in all judicial districts equally.”[80] The court rejected the government’s argument that any relief should be limited to the plaintiffs and their members, noting that “it would be impractical, if not impossible, to fashion party-tailored relief here,” given the volume and variety of affected trade organizations’ members.[81] The court found no basis for the “rare” remedy of remand without vacatur, concluding that “[t]here is no likelihood that FDA can justify its decision on remand, given that the final rule exceeds its authority under the FDCA.”[82] Accordingly, the court granted the plaintiffs’ motions for summary judgment, denied the government’s cross-motion, and ordered the final rule set aside and vacated.[83]

Current Status

The government did not appeal the district court’s decision to the Fifth Circuit. Shortly after the opinion was issued, FDA posted a notice on its website confirming that the final rule had been vacated and that the agency would not be pursuing an appeal.[84] Because the court’s order vacated the rule with nationwide effect, the phased enforcement timeline that was set to begin in May 2025—including adverse event reporting, registration and listing, labeling requirements, and eventually premarket review— did not occur and was rendered moot.[85]

In September 2025, FDA officially implemented the vacatur and rescinded the final rule.[86] This outcome is consistent with the current administration’s broader posture toward regulatory restraint. As noted in the opinion itself, the defendants in the case include officials appointed by President Trump who have demonstrated skepticism toward expansive federal regulation of healthcare services.[87]

Impact

The ACLA decision represents a decisive, if not necessarily final, resolution of the longstanding debate over FDA’s authority to regulate laboratory-developed tests. The decision is significant for several reasons.

First, the opinion provides the most thorough judicial analysis to date of the boundary between FDA’s device authority under the FDCA and CMS’s oversight of clinical laboratories under CLIA. By holding that LDTs are professional services rather than manufactured devices, the court drew a clear line that requires congressional action before FDA could feasibly reattempt to assert jurisdiction over this sector.[88] Put another way, the court’s reasoning effectively forecloses not only the specific regulatory amendment at issue in this case—the addition of “including when the manufacturer of these products is a laboratory” to 21 C.F.R. § 809.3(a)—but also any future attempt by FDA to regulate LDTs as devices through rulemaking, guidance, or enforcement action, absent new legislation. The opinion’s sweeping analysis of the FDCA’s text, structure, and history leaves little room for FDA to craft an alternative regulatory approach under existing statutory authority.[89] This distinguishes ACLA from cases in which vacatur merely requires an agency to correct procedural deficiencies or provide a better explanation for its decision; here, the court concluded that the agency’s fundamental jurisdictional claim was “foreclosed” by the statute itself.[90] As explained below, this reading also reinforces the principle, reaffirmed by the Supreme Court in Loper Bright, that courts must exercise their “independent judgment in deciding whether an agency has acted within its statutory authority” rather than deferring to the agency’s own view of its powers.[91]

Second, the decision highlights the practical consequences of FDA’s asserted authority, including the billions of dollars in compliance costs, the vast increase in premarket applications FDA would need to review, and the implication that an entire profession has been engaged in criminal activity for decades under the FDCA’s penal provisions.[92] These consequences, the court suggested, only underscore the “implausibility” of FDA’s statutory reading.[93]

The ACLA decision also has potentially broader implications for the scope of FDA’s authority in other contexts. The court’s reasoning that FDA may regulate only tangible “devices” and not the professional services that make use of those devices could be relevant to emerging questions about FDA’s authority over other technology-enabled healthcare services, including software-based diagnostic tools and artificial intelligence applications in clinical settings. The court’s analogies—comparing a laboratory’s performance of a test to a radiologist reading an x-ray or a surgeon performing an operation using surgical instruments—suggest a broader principle that the use of regulated devices in the course of delivering a professional service does not convert the service itself into a device subject to FDA jurisdiction.[94] This reasoning could be invoked in future disputes over FDA’s authority to regulate clinical decision-support software, telemedicine platforms, or other hybrid products and services that blur the line between tangible devices and professional healthcare activities.

The decision also carries important implications for the “regulatory gap” that now exists with respect to certain categories of laboratory-developed tests. While CLIA establishes standards for laboratory proficiency, quality control, and personnel qualifications, it does not address the clinical validity of tests—that is, the accuracy with which a test identifies, measures, or predicts the presence or absence of a clinical condition. As the government argued in its briefing, “if a laboratory test system lacks clinical validity . . . [it] will not provide meaningful diagnostic information no matter how great the expertise or experience of the professionals performing [it].”[95] FDA’s final rule was motivated in part by evidence that some laboratory-developed tests have yielded inaccurate results, potentially causing patient harm.[96] With the final rule vacated, clinical validity remains unregulated at the federal level for most LDTs, and addressing this gap will likely require legislative action. Industry observers have noted that this gap may provide additional impetus for Congress to craft a tailored legislative framework that addresses patient safety concerns without subjecting the entire laboratory testing industry to FDA’s device regime.

Finally, the decision intersects with broader themes in administrative law following the Supreme Court’s landmark decisions in Loper Bright and Corner Post.[97] Loper Bright overruled Chevron deference and directed courts to find the “best” reading of a statute using traditional tools of statutory interpretation, rather than deferring to an agency’s “reasonable” interpretation.[98] The ACLA court applied precisely this framework, engaging in a detailed independent analysis of the FDCA’s text, structure, and history to reach its conclusion that the statute does not authorize FDA to regulate LDTs as devices.[99] Had Chevron still been in effect, the outcome might have been different: FDA’s decades-long assertion that laboratory-made IVD test systems fall within its jurisdiction might have been sustained as a “permissible” reading of the statute, even if a court independently analyzing the issue would have reached the opposite conclusion.[100] The ACLA decision thus serves as a powerful illustration of Loper Bright’s practical impact—demonstrating that the demise of Chevron deference can produce materially different outcomes in cases where agencies assert regulatory authority at the outer boundaries of their statutory mandates.

In Corner Post, the Supreme Court held that a claim under the Administrative Procedure Act (APA) does not accrue, for purposes of 28 U.S.C. § 2401(a)’s six-year statute of limitations, until the plaintiff is injured by final agency action—rather than when the agency action is published or becomes final. The ACLA decision did not need to rely on Corner Post’s statute-of-limitations holding, because the timeliness of the lawsuit following the agency’s final action was not the issue: the FDA’s final rule was published on May 6, 2024, and the plaintiffs challenged it promptly. Instead, the ACLA court cited Corner Post for a different proposition drawn from Justice Kavanaugh’s concurrence: that vacatur is the appropriate APA remedy for unlawful agency action and that it has nationwide effect, i.e. it is not limited to the specific plaintiffs. The court quoted Justice Kavanaugh’s observation that the Supreme Court has “affirmed ‘countless decisions that vacated agency action, including agency rules,’” and that those decisions “vacated challenged agency rules rather than merely providing injunctive relief that enjoined enforcement of the rules against the specific plaintiffs”[101] Relying on this framework, the ACLA court vacated the FDA’s final rule in its entirety rather than merely enjoining its enforcement against the Laboratory Plaintiffs.

With the government’s decision not to appeal, the ACLA decision now stands as the definitive judicial pronouncement on the boundary between FDA’s device authority and CMS’s oversight of clinical laboratories. Looking ahead, the most straightforward path toward resolving the regulatory status of LDTs is congressional action. Congress has repeatedly considered but failed to pass legislation addressing LDT regulation—including the VALID Act, which would have created a new regulatory pathway separate from both drugs and devices, and the VITAL Act, which would have expressly classified LDTs as professional health care activities regulated under CLIA.[102] New versions of both bills have been introduced in subsequent Congresses without success, and the political dynamics surrounding any such legislation remain complex.

Whether it becomes the catalyst for the kind of comprehensive congressional action that some stakeholders have long sought remains to be seen. In the meantime, the clinical laboratory industry will continue to operate under the existing CLIA framework, and the question of whether that framework adequately protects patients from clinically invalid tests will continue to animate the policy debate.

 

* Tina Papagiannopoulos is a Knowledge Management Lawyer at Sidley Austin, LLP, where she supports the firm’s Food, Drug, and Medical Device practice and Global Life Sciences practice area team.

[1]   Am. Clinical Lab. Ass’n v. U.S. Food & Drug Admin., 776 F. Supp. 3d 554 (E.D. Tex. 2025).

[2]   Medical Devices; Laboratory Developed Tests, 89 Fed. Reg. 37,286 (May 6, 2024).

[3]   Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024).

[4]   42 U.S.C. § 263a(b); ACLA, 776 F.Supp.3d at 562–63.

[5]   42 U.S.C. § 263a(f)(1); ACLA, 776 F.Supp.3d at 563.

[6]   42 C.F.R. § 493.1443; ACLA, 776 F.Supp.3d at 563.

[7]   See 42 U.S.C. § 263a(f)(3); 42 C.F.R. § 493.801; ACLA, 776 F.Supp.3d at 562–63.

[8]   See Complaint ¶¶ 27–31, Am. Clinical Lab. Ass’n v. U.S. Food & Drug Admin., No. 4:24-CV-479-SDJ (E.D. Tex. May 29, 2024), ECF No. 1 [hereinafter ACLA Compl.].

[9]   Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539.

[10]  89 Fed. Reg. 37,286, 37,289.

[11]  Id.

[12]  Id.

[13]  Id.

[14]  Id. at 37,286 n.1.

[15]  89 Fed. Reg. 37,286.

[16]  Id. at 37,445.

[17]  Id. at 37,295–311.

[18]  Id. at 37,296–97.

[19]  Id. at 37,291–92.

[20]  Id. at 37,289–90.

[21]  Id. at 37,291–93.

[22]  U.S. Food & Drug Admin., Laboratory Developed Tests Final Rule, Final Regulatory Impact Analysis, Docket No. FDA-2023-N-2177, at 50.

[23]  Id. at 127.

[24]  Id. at 49.

[25]  ACLA, 776 F.Supp.3d 554 at 560–61.

[26]  Id. at 571–72.

[27]  Defendants’ Cross-Motion for Summary Judgment at 16–17, Am. Clinical Lab. Ass’n v. U.S. Food & Drug Admin., No. 4:24-CV-479-SDJ (E.D. Tex. Oct. 25, 2024), ECF No. 54 [hereinafter FDA MSJ].

[28]  Id.

[29]  Id.

[30]  See Plaintiffs’ Motion for Summary Judgment at 6–7, Am. Clinical Lab. Ass’n v. U.S. Food & Drug Admin., No. 4:24-CV-479-SDJ (E.D. Tex. Sept. 3, 2024), ECF No. 20 [hereinafter ACLA MSJ].

[31]  FDA MSJ at 19 (describing the IVD test system as an “apparatus” or “contrivance” composed of “reagents, instruments, and other articles” that “function together to produce a test result”).

[32]  ACLA v. FDA, 776 F.Supp.3d 554 at 559–60.

[33]  Id.

[34]  Id.

[35]  21 U.S.C. § 321(h)(1).

[36]  ACLA, 776 F. Supp. 3d at 575, 579–81.

[37]  Id. at 575–78.

[38]  Id. at 578–79 (citing ClearCorrect Operating, LLC v. ITC, 810 F.3d 1283, 1290–94 (Fed. Cir. 2015); Kaiser Aluminum & Chem. Corp. v. U.S. Consumer Prod. Safety Comm’n, 574 F.2d 178, 180 (3d Cir. 1978), AMP Inc. v. Gardner, 389 F.2d 825, 826–27 & n.4 (2d Cir. 1968)).

[39]  Id. at 576–77.

[40]  Id. at 577.

[41]  Id.

[42]  Id. at 577–78.

[43]  Id. at 576–77.

[44]  Id. at 576.

[45]  Id. at 580–84.

[46]  Id. at 563–64.

[47]  Id.

[48]  Id. at 563–64 (citing S. Rep. No. 90-724 (1967), as reprinted in 1967 U.S.C.C.A.N. 2076, 2084).

[49]  Id. at 564 (citing H.R. Rep. No. 100-899, at 11 (1988), as reprinted in 1988 U.S.C.C.A.N. 3828, 3831).

[50]  Id. (quoting H.R. Rep. No. 100-899, at 12 (1988)).

[51]  Id. at 583–84.

[52]  Id.

[53]  Id.

[54]  Id. at 564–69.

[55]  Id. at 564–65.

[56]  Id. at 565–66 (quoting IVD Policy Will Not Include Exemptions for “Standard-of-Care” Tests, The Gray Sheet (Oct. 11, 1993)).

[57]  Id. at 566; 61 Fed. Reg. 10,484, 10,485 (Mar. 14, 1996); 62 Fed. Reg. 62,243, 62,249 (Nov. 21, 1997).

[58]  ACLA, 776 F. Supp. 3d at 566; 79 Fed. Reg. 59776 (Oct. 3, 2014); 79 Fed. Reg. 59779 (Oct. 3, 2014).

[59]  ACLA, 776 F. Supp. 3d at 566–67 (quoting H.R. Rep. No. 114-531, 72–73 (2016)).

[60]  ACLA, 776 F. Supp. 3d at 567; U.S. Food & Drug Admin., Discussion Paper on Laboratory Developed Tests (LDTs) (Jan. 13, 2017), https://www.fda.gov/media/102367/download.

[61]  See ACLA Compl. Ex. F at 3–4; ACLA MSJ at 13–14.

[62]  See ACLA MSJ at 14–15; ACLA, 776 F. Supp. 3d at 567-68; Verifying Accurate Leading-Edge IVCT Development (VALID) Act of 2020, H.R. 6102, 116th Cong. (2020); VALID Act of 2021, H.R. 4128, 117th Cong. (2021); VALID Act of 2023, H.R. 2369, 118th Cong. (2023); Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, S. 3512, 116th Cong. (2020); VITAL Act of 2021, S. 1666, 117th Cong. (2021).

[63]  ACLA MSJ at 32–33 (quoting, Rest. Law Ctr. V. U.S. Dep’t of Lab., 2024 WL 3911308, at *8 n.9; West Virginia v. EPA, 597 U.S. 697, 721, 724 (2022)).

[64]  Id. at 32.

[65]  FDA MSJ at 18–20 (citing 21 U.S.C. § 321(h)(1); United States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969)).

[66]  FDA MSJ at 19.

[67]  Id. at 3, 36–41.

[68]  Id. at 3–4.

[69]  Id. at 21–26.

[70]  ACLA, 776 F. Supp. 3d at 574.

[71]  Id. at 574, 585.

[72]  Id. at 571.

[73]  Id. at 571 n.10.

[74]  Id.

[75]  Id. at 582–83.

[76]  Id.

[77]  Id. at 583.

[78]  Id. at 583 (quoting Pugin v. Garland, 599 U.S. 600, 610 (2023)).

[79]  Id. at 583–84 (quoting Van Buren v. United States, 593 U.S. 374, 394 (2021).

[80]  Id. at 584–85 (quoting Braidwood Mgmt., Inc. v. Becerra, 104 F.4th 930, 951-952 (5th Cir. 2024); Tex. Med. Ass’n v. U.S. Dep’t of Health & Hum. Servs., 110 F.4th 762, 789 (5th Cir. 2024)).

[81]  Id. at 585.

[82]  Id. at 584–85

[83]  Id.

[84]  See U.S. Food & Drug Admin., Laboratory Developed Tests, https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests (last visited Mar. 15, 2026).

[85]  See id. at 570–71.

[86]  U.S. Food & Drug Admin., Final Rule, Regulation Identification Number 0910–AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur, 90 Fed. Reg. 45134 (Sept. 19, 2025).

[87]  ACLA, 776 F. Supp. 3d at 560 n.1.

[88]  Id. at 574, 583–85.

[89]  ACLA, 776 F. Supp. 3d at 574–85.

[90]  Id. at 574.

[91]  Loper Bright, 603 U.S. at 391–92, 395; ACLA, 776 F. Supp. 3d at 572–74.

[92]  ACLA, 776 F. Supp. 3d at 582–85.

[93]  Id. at 583–84.

[94]  Id. at 577–78 (analogizing laboratory-developed tests to radiological interpretations and surgical procedures).

[95]  FDA MSJ, supra note 61, at 39 (quoting 89 Fed. Reg. at 37,340).

[96]  Id. at 1–2 (describing “numerous examples of potentially inaccurate, unsafe, ineffective, or poor quality IVDs offered as LDTs that have or may have caused patient harm”).

[97]  See Loper Bright, 603 U.S. 369; Corner Post v. Bd. of Governors of the Fed. Res. Sys., 603 U.S. 799 (2024).

[98]  Loper Bright, 603 U.S. at 400–403.

[99]  ACLA, 776 F. Supp. 3d at 572–74 (citing Loper Bright, 603 U.S. at 391, 395, 400).

[100] See Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843 (1984) (directing courts to defer to an agency’s “permissible construction of the statute”); Loper Bright, 603 U.S. at 400 (overruling Chevron and holding that “a merely ‘permissible’ reading is not enough”).

[101] ACLA, 776 F. Supp. 3d at 584 (citing Corner Post, 603 U.S. at 830–31).

[102] See ACLA Compl. ¶¶ 86–89 (describing the VALID Act and VITAL Act); ACLA, 776 F. Supp. 3d at 567–68.