By qualifying tools like biomarker tests, outcome measures, and digital health technologies, the FDA aims to enhance predictability and efficiency in regulatory reviews. The voluntary program provides a framework for assessing tools’ suitability and utility, reducing the need for repeated evaluations for each device submission. Previously, tools were evaluated on a case-by-case basis, but the MDDT program offers a standardized process, benefiting both device sponsors and regulators. Qualified tools cover various medical specialties and device types, offering a clear pathway for developers to navigate regulatory requirements. Device sponsors can reference qualified MDDTs in their submissions, streamlining the review process. The program encourages collaboration and innovation while ensuring safety and effectiveness standards are met
May 7, 2024