The voluntary MDDT program helps to improve predictability and efficiency in device development and regulatory review. Tools such as biomarker tests, clinician-reported outcome measures, patient-reported outcome measures, or non-clinical assessment models such as animal or computational models, and digital health technologies like sensors or wearables, play an important role in helping the FDA understand how medical devices work, in terms of safety, effectiveness, and other aspects of performance. The MDDT program is a way for the FDA to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices. Why the FDA Developed the MDDT Qualification Process CDRH Funding Opportunities: Small Business Innovation Research (SBIR) Grant Program.MDDT Qualification and the Qualification Process.Qualified Medical Device Development Tools (MDDTs).Why the FDA Developed the MDDT Qualification Process.The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development, timely evaluation of medical devices, and promote innovation by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.
