FDA Expectations for Real-World Imaging Data: What Makes RWE Regulatory-Grade
Real-world evidence (RWE) built from real-world imaging data (RWiD) is becoming a cornerstone of healthcare innovation. Routine PACS (Picture Archiving and Communication System) images such as x-rays, CT, MRI, and ultrasound exams are now recognized as a powerful window into patient outcomes, treatment response, and disease biology. From regulatory decisions and clinical trials to AI development and post-market surveillance, imaging data is rapidly becoming one of the strongest real-world evidence sources. As RWiD applications continue to expand, the FDA is sharpening its expectations around how imaging-derived RWE should be collected, curated, and validated to achieve true regulatory-grade credibility. Imaging Data Matters — For Research, Patient Care, and Regulation Imaging data is crucial to research and advancing patient care because it provides objective, reproducible, and detailed evidence of how diseases evolve and how therapies work in the body. This importance is also recogniz...