FDA Qualifies First Tool under Medical Device Development Tools (MDDT) Program  

The FDA recently qualified the first tool under the medical device development tools (MDDT) program.  This is a voluntary process that can reduce regulatory burden for medical device developers and FDA reviewers by qualifying tools that can aid in the development and evaluation of medical devices.  MDDT qualification can help streamline the FDA review process for a new medical device by addressing questions about data validity and reducing the time and resources needed for new product development while still maintaining the same level of patient safety.  Once a MDDT is qualified, it is then publically listed on the FDA’s MDDT web page.

On October 19, 2017, the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) became the first qualified tool in the MDDT program.  This patient-reported outcome (PRO) tool can be used to quantify patients’ health status, including the symptoms, physical and social limitations, and impact on quality of life due to heart failure syndrome.

MDDT’s are classified under three categories which include clinical outcome assessments, biomarker tests, and nonclinical assessment models.  Any organization can voluntarily submit a proposal for their tool to [email protected] free of charge for qualification.  Following the initial proposal phase, the FDA considers the MDDT description, context of use, public health impact, strength of evidence, and conducts an assessment of advantages and disadvantages of the tool.

Once the FDA has evaluated a tool to ensure that it produces scientifically-plausible measurements and works as intended within the specified context of use, it is then considered qualified.  The final guidance for the Qualification of Medical Device Development Tools which goes into further detail about the context of use can be found at the attached link.

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