The FDA is constantly revising the evaluation of new medical technologies, especially those powered by software, artificial intelligence, and real-world data. Right now, these are the 5 new trends reshaping how MedTech innovators design, validate, and bring new products to market.
A Dedicated Home for Digital Health
The Digital Health Center of Excellence (DHCoE) centralizes FDA expertise on Software as a Medical Device (SaMD), mobile apps, and digital tools. This initiative provides clearer pathways and early engagement opportunities for digital innovators.
AI/ML-enabled devices and a predetermined change control plan
AI/ML-enabled devices are moving from concept to lifecycle regulation. The FDA now encourages inclusion of a Predetermined Change Control Plan (PCCP), outlining how algorithms will evolve and remain safe after deployment.
Real-World Evidence Gains Regulatory Weight
The FDA increasingly accepts real-world evidence (RWE) from electronic health records, registries, and wearables to support approvals and label changes.
Software Pre-Cert Lessons: Quality Over Product Snapshots
While the Software Precertification Pilot has evolved, its focus on organizational excellence, postmarket monitoring, and continuous improvement continues to guide digital health regulation.
Expedited Pathways Stay Key to Innovation
Programs like the Breakthrough Devices Program offer earlier engagement and faster review for technologies addressing unmet medical needs.
The Bottom Line
The FDA’s approach to medtech is becoming more agile, data-driven, and lifecycle-focused. Companies that invest in organizational quality, RWE capability, and early regulatory collaboration will be best positioned to bring safer, smarter technologies to market faster.
If you have questions about the development process, feel free to reach out for help. We do hundreds of free consults every year to help guide innovators along their path of device development.