Why Human Factors Matters in Medical Device Development Human factors is not simply a labeling or documentation exercise. For medical device manufacturers, human factors and usability engineering are fundamental parts of designing a device that intended users can operate safely and…
FDA eSTAR medical device submission 2026: Why Submission Readiness Starts Earlier
eSTAR in 2026: Why FDA Submission Readiness Must Start Before the Template Is Opened FDA’s electronic Submission Template and Resource, or eSTAR, has changed how many medical device submissions are organized and prepared. But sponsors should be careful not to confuse…
AI-Enabled Medical Device Clinical Development: FDA PCCP & Lifecycle Planning
Clinical Development for AI-Enabled Medical Devices: Plan for Change Before the Algorithm Changes Traditional medical-device development often assumes that the version evaluated during clinical development will remain relatively stable through authorization and commercial use. AI-enabled medical devices can introduce a different…
FDA TAP Program in 2026: What Breakthrough Device Sponsors Need to Know
FDA TAP Expansion in 2026: What Breakthrough Device Sponsors Should Know About Clinical Development The FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot has become increasingly relevant for medical device innovators developing technologies intended to address significant unmet clinical needs….