FDA Regulations for PACA and Medical Imaging Software : A Complete 2026 Guide
FDA Regulations for PACA and Medical Imaging Software : A Complete 2026 Guide You can spend months building medical imaging software, only to discover a costly surprise. One wrong FDA classification can delay your launch or keep your product off the US market. That’s the reality for many healthcare software companies. Whether you’re developing a DICOM viewer, PACS platform , or AI-powered imaging solution, understanding the FDA regulations for medical imaging software is essential from the start. What Counts as Medical Imaging Software Under FDA Rules? Not all medical imaging software is regulated by the FDA. What matters isn’t whether your software works with medical images, but what it’s designed to do. If your software analyzes, processes, or helps diagnose a medical condition, it’s likely regulated as a medical device. If it simply stores, displays, or transfers images without influencing clinical decisions, it may not fall under FDA regulation. Understanding this disti...