Digital Health Software Precertification (Pre-Cert) Program
Digital Health Software Precertification (Pre-Cert) Program
GOALS
- Develop tailored and pragmatic regulatory oversight
- Trust organizations with demonstrated culture of quality and organizational excellence
- Leverage transparency of organization’s excellence and product performance across entire lifecycle
- Streamline premarket review to verify the continued safety, effectiveness, and performance
INTENTIONS
- Leverage information from all available sources to be more efficient and streamlined without compromising safety and effectiveness
- Enable modern and tailored approach to allow timely software iterations and changes
- Ensure high-quality by enabling companies to demonstrate their embedded culture of quality and organizational excellence
- Learn, adapt, adjust key elements based on program effectiveness
Image credit: FDA