FDA requirements are U.S. regulatory expectations that may apply to software when it functions as a medical device or supports regulated medical products and workflows. Which rules apply depends on the software’s intended use and role; not every healthcare application is regulated by the FDA.
For software within FDA oversight, requirements can shape development, testing, risk management, documentation, and controls over changes after release. Security matters because vulnerabilities or unauthorized changes may affect safety, performance, or the reliability of medical functions. Teams should determine regulatory scope early, build appropriate security safeguards into the product lifecycle, and keep traceable evidence of design decisions, testing, and updates.