FDA Qualifies First Medical Device Development Tool


Posted October 27, 2017

The Food and Drug Administration (FDA) has qualified the first tool under its new Medical Device Development Tool (MDDT) program. After approximately 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in their submissions.

“Use of this tool could expedite the regulatory submission and review process by reducing the number of subjects in clinical trials, saving money, increasing confidence in data quality, and improving review speed and consistency, while maintaining the same level of safety and effectiveness for patients,” the FDA said in an email statement.

The FDA released final guidance in August that described how it would qualify an MDDT. Once qualified, MDDTs can then be used in clinical trials to support device submissions and postapproval studies without FDA review staff having to reconfirm the tool’s suitability and utility, according to the agency.

“MDDT qualification helps streamline the FDA review process. It can help address questions about data validity and reduce the time and other resources needed for new product development while maintaining the same level of patient safety,” explained Hilda F. Scharen, a Captain in the U.S. Public Health Service and director of MDDTs at FDA’s Center for Devices and Radiological Health (CDRH), and CDRH Director Jeffrey Shuren in a post on the FDA’s blog.

The 23-item KCCQ is a patient-reported outcome (PRO) tool that is already used by researchers, clinicians, and medical device developers to quantify patients’ health status, including the symptoms, physical and social limitations, and impact on quality of life due to heart failure syndrome.

According to the FDA, “The use of high-quality PRO tools can improve health outcomes and understanding of how patients experience treatments. PROs enable the FDA to incorporate patient feedback into the review of medical devices, streamline the review process, and get devices to patients faster without compromising on safety or effectiveness.”

Any tool developer, medical device manufacturer, healthcare provider, or researcher can submit a proposal for their tool to be considered by FDA for qualification. More information about the qualification process is available in the MDDT Program Federal Register notice.

The FDA maintains a public list of qualified MDDTs that summarizes the evidence and basis of qualification for the tool.