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An organ-on-a-chip is a small laboratory model that uses living cells and a controlled microenvironment to reproduce selected features of a tissue or organ. It is not a complete artificial organ: researchers use it to investigate how tissue behaves, responds to disease, or reacts to drugs and other exposures.
What is an organ-on-a-chip?
An organ-on-a-chip is an in vitro research platform—one used outside a living organism—that combines microfluidics, microfabrication, and cell culture to model particular aspects of tissue-level physiology. The National Library of Medicine’s MeSH vocabulary groups organ-on-a-chip with terms including “tissue chip” and “microphysiological system” (MPS). NLM MeSH describes MPS devices as using these technologies and three-dimensional cell culture to reproduce organ- or tissue-level functions.
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The cells may be human or animal. Depending on the model, a chip can also use tissue explants or organoid formations. The goal is to recreate a defined set of functional or structural features—not to shrink an entire organ into a device. NICEATM’s working definition describes an MPS as a cell-, explant-, or organoid-based platform whose microenvironment supports biochemical, electrical, or mechanical responses relevant to specific tissue functions. NICEATM
How does an organ-on-a-chip work?
Researchers place cells in a small engineered device and control conditions around them. Microfluidic channels can move fluid through the model; the device and culture design can also provide biochemical conditions, tissue architecture, or mechanical and electrical cues. Which features are present depends on the specific chip. A chip does not necessarily reproduce all of the conditions found in the body.
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NCATS describes transparent chips lined with living cells and modular systems that can link models of different organs. NCATS Linking models can help researchers explore how an effect in one tissue may relate to another, but it does not amount to a complete model of the human body.
What are tissue chips used for?
Researchers use them to study normal tissue function and disease, and to investigate how tissue responds to drugs, chemicals, or pathogens. The intended applications include examining candidate drug safety and efficacy and exploring toxicant effects. A model’s usefulness depends on the tissue represented, the question being asked, and evidence that the system performs appropriately for that application.
Example: evaluating food chemicals
The FDA reports that it is evaluating a liver-chip to better understand how chemicals in food affect the human body. FDA This is a specific research application; it does not establish that every liver-chip, or every organ-chip design, can answer the same question.
What can—and can’t—an organ-on-a-chip tell us?
The technology aims to improve how well laboratory models predict human safety and effectiveness, but a chip’s predictive value is not guaranteed across compounds, tissues, or research uses. The FDA-NIH memorandum describes MPS as an emerging technology and identifies regulatory acceptance as important to wider industrial adoption. FDA-NIH MOU
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Do not treat an organ-on-a-chip as a universal replacement for animal studies or clinical evidence. Nor does the category itself mean that a particular platform has been validated for a particular test. When judging a system, look for evidence tied to its specific intended use.
What does FDA’s 2026 update mean?
FDA’s current New Approach Methodologies (NAMs) page says a September 2026 direct final rule recognizes that nonclinical tests may include NAMs such as organs-on-chips, cell-based assays, and computer models. The agency says the rule does not require a specific method and does not change evidentiary standards. FDA NAMs
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This is recognition of organ-on-a-chip systems within the terminology for nonclinical testing. It is not blanket FDA approval or qualification of all organ-chip devices, and it does not by itself establish that a model is suitable for every regulatory question.
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1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteHow to compare organ-on-a-chip systems
There is no single design that fits every tissue or research question. A useful comparison focuses on the model’s purpose and supporting evidence rather than the “organ-on-a-chip” label alone.
- Tissue modeled: Which organ or tissue does the system represent, and what features does it aim to reproduce?
- Cell source: Does it use human or animal cells, tissue explants, or organoid formations? Which cell types are included?
- Culture and cues: Does the design use three-dimensional culture, fluid flow, or mechanical or electrical signals?
- Connections: Can it link multiple tissue models, and is that relevant to the question being studied?
- Intended application: Is it designed for disease modeling, toxicology, pathogen research, or drug efficacy?
- Performance evidence: What evidence supports the model for that particular use?
Is an organ-on-a-chip a real organ?
No. It is a laboratory model built to reproduce selected features of tissue or organ function. It can contain living cells and provide a controlled environment, but it is not a complete, functioning organ for transplantation or use in a person.
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