Home > Are biological age tests FDA approved? How aging tests are regulated
Are biological age tests FDA approved? How aging tests are regulated
Prepared by: Research Desk. Sources are linked for verification.
Data point first: We aren’t aware of any consumer epigenetic “biological age” test that is FDA-cleared or FDA-approved to measure aging. Most are offered as laboratory-developed tests (LDTs). LDTs sit in a regulatory space that changed twice between 2024 and 2025. Here’s what the label on your test kit really means.
Contents
What is a laboratory-developed test?
An LDT is a test designed, manufactured and used within a single laboratory. A lab that analyses your saliva or blood sample with its own in-house method is typically offering an LDT. That’s different from a test kit made by a manufacturer and sold to many labs, which usually needs FDA marketing authorization as an in vitro diagnostic (IVD) device.
The 2024–2025 regulatory rollercoaster
FDA has historically taken a hands-off approach to most LDTs, while maintaining that it had authority over them. Then:
6 May 2024: FDA issued a final rule amending the definition of “in vitro diagnostic products” to add the words “including when the manufacturer of these products is a laboratory”. This would have phased LDTs into device regulation [1].
31 March 2025: A federal district court vacated that final rule [1].
19 September 2025: FDA issued a final rule reverting the regulation to its text before the May 2024 rule [1][2].
Net effect today: LDTs, including most biological-age tests, generally reach consumers without FDA premarket review of their analytical or clinical validity.
What CLIA does and doesn’t cover
Most U.S. clinical labs that test human samples for health purposes must be certified under the Clinical Laboratory Improvement Amendments (CLIA), which the Centers for Medicare & Medicaid Services administers [3].
CLIA certification generally addresses…
It does NOT establish…
Lab quality systems and personnel qualifications
That the test result means anything for an individual’s health
Proficiency testing and quality control
That the test predicts disease or lifespan in you
Analytical performance of the lab’s processes
That changing your score improves outcomes
In short, CLIA helps make sure the lab measures things reliably. It doesn’t validate the clinical meaning of a biological-age score. A well-run, CLIA-certified lab can still report a number whose health meaning for an individual hasn’t been established. Both questions matter, and they’re answered by different kinds of evidence.
Why the clinical-meaning question is hard
Epigenetic clocks are research tools trained to predict different things:
Chronological age: the original Horvath clock [4].
Mortality and morbidity risk: PhenoAge and GrimAge [5][6].
Pace of aging: DunedinPACE [7].
Studies show strong associations at the population level. For example, GrimAge predicted time to death and to heart disease across thousands of people [6], and DunedinPACE showed high test-retest reliability and predicted morbidity, disability and mortality [7]. A population association, though, isn’t the same as a validated individual diagnostic. That’s exactly the kind of claim FDA review of a medical device would examine. See our clock guide for the details.
Claims to watch for
“Medical-grade” or “clinically validated.” Ask: validated for what outcome, in which study, and is it published?
“Your biological age is X years.” Different clocks can give the same person quite different results.
“Y years younger” claims. Short-term changes in a clock score haven’t been shown to change real health outcomes.
“FDA-approved.” Check FDA’s device databases. If you can’t find the product, the claim is false.
Five questions to ask before you buy
Which clock or clocks does the test use, and is the algorithm published?
Is the lab CLIA-certified? (Ask for its CLIA number.)
What sample type is used (blood or saliva), and was the clock developed on that sample type?
What’s the test’s technical repeatability? Would you get the same result twice?
How is your genetic and epigenetic data stored, shared or sold?
Outside the U.S.
In the EU, in vitro diagnostics are governed by the IVD Regulation (IVDR), and in-house tests have their own conditions. We’ll add sourced country notes over time.
Status checked: 18 October 2026. Not legal advice.
Not medical advice. This page reports published research and regulatory records for information only.