For most of the last two decades, most genetic tests — including nearly all direct-to-consumer tests — have operated as "laboratory developed tests" (LDTs), which the FDA has authority over in principle but has historically chosen not to actively enforce against, a practice called enforcement discretion. In May 2024, the FDA tried to end that practice with a final rule that would have phased in full medical-device-style regulation for LDTs over four years, affecting an estimated 80,000 existing tests across roughly 1,200 laboratories.
The Rule Was Struck Down — And the FDA Didn't Fight Back
The rule faced immediate legal challenges from the American Clinical Laboratory Association and the Association for Molecular Pathology, who argued the FDA had exceeded its statutory authority. On March 31, 2025, a federal district court in Texas agreed, ruling that LDTs are medical services regulated under CLIA — not medical devices subject to FDA's authority — and vacated the rule entirely. In a significant development, HHS chose not to appeal the ruling, and the FDA formally rescinded its own rule in September 2025, reverting the legal definition of in vitro diagnostic products back to its pre-2024 language.
| Date | Event |
|---|---|
| May 2024 | FDA issues final rule to phase out enforcement discretion for LDTs over 4 years |
| March 2025 | Federal court vacates the rule, ruling FDA lacks statutory authority over LDTs |
| May 2025 | HHS declines to appeal the ruling |
| September 2025 | FDA formally rescinds its own 2024 rule |
What This Means Practically in 2026
The net effect: most genetic testing labs, including the large majority of DTC genetic testing companies, are back to being regulated primarily through CLIA (administered by CMS), not through direct FDA device oversight. CLIA certification addresses laboratory process quality and reproducibility — it does not certify that a specific genetic claim is clinically valid or meaningful, which is a distinction covered in more depth in our DTC vs. clinical-grade testing guide. The FDA retains authority to intervene in individual cases it considers a significant public health risk, but broad, systematic regulation of the LDT category is off the table for now, absent new legislation from Congress — and a previous legislative attempt to give FDA explicit authority in this area (the VALID Act) did not pass and hasn't been reintroduced.
As of 2026, DTC genetic testing labs are not required to seek FDA clearance or approval, and the compliance deadlines from the 2024 rule are void. This doesn't mean testing is unregulated — CLIA still applies — but it does mean consumers should continue treating CLIA/CAP certification, not FDA approval, as the more meaningful quality signal when evaluating a genetic testing company, since that's where the actual enforceable oversight currently sits.
Why This Debate Isn't Over
Industry groups (hospital labs, clinical laboratories) welcomed the reversal as avoiding burdensome new compliance costs, particularly for specialized tests like pediatric or rare-disease assays that wouldn't otherwise be commercially developed. Consumer advocacy groups that supported the original rule have expressed continued interest in some form of updated oversight framework. Given the current political environment, most legal observers don't expect a quick legislative fix, but this remains an area worth watching for anyone following genetic testing regulation closely.
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Get Sequenced with Dante Labs → 10% off with code GENOMEFor more on what lab certifications actually mean, see our DTC vs. clinical-grade testing guide, and for the reproductive-data-specific privacy landscape, our advanced family planning guide covers 2026 state genetic privacy law developments in depth.