How FDA Policy And NCATS Are Supporting Organs On Chips

Christine Happle explains how FDA and NIH efforts are converging to move organ‑on‑chip and microphysiological systems from innovation toward regulatory credibility. She outlines how FDA has clarified expectations for new approach methodologies (NAMs) through structured qualification pathways, most notably the ISTAND program, which has now become a permanent mechanism for evaluating non‑animal methods within a defined context of use.

Happle emphasizes that while the FDA is signaling openness to NAM‑generated data, regulatory acceptance depends on rigorous validation, reproducibility, and clear articulation of how a model will be used in decision‑making. She highlights NCATS’ long‑standing role in preparing the field for this moment, noting that its Tissue Chips program—launched in 2012—has evolved from early technology development into disease modeling, clinical trials‑on‑a‑chip, and the creation of translational centers specifically designed to support regulatory adoption.

Beyond technology, Happle stresses the importance of community building and data sharing. Through NCATS‑supported initiatives such as the International MPS Society and the MPS World Summit, as well as major NIH investment in the Complement Animal Research and Experimentation Program, NCATS is working to align developers, end users, and regulators around shared validation standards.