FDA Qualifies 2nd Medical Device Development Tool

Regulatory NewsRegulatory News | 07 May 2018 |  By 

A 21-item questionnaire designed to measure quality of life for heart failure patients became the second medical device development tool (MDDT) to receive US Food and Drug Administration (FDA) qualification.

Companies and study sponsors can use the University of Minnesota’s (UMN) MDDT—the Minnesota Living with Heart Failure Questionnaire (MLHFQ)—as an aid in the development of a device and evaluating the effectiveness of its intended use.

MLHFQ was created in 1985 at a time when there was a gap between tools that help determine whether symptoms were being relieved and measuring quality of life, Carol Grutkoski, technology marketing manager at UMN, told Focus. Today, the newly qualified MDDT has been licensed “over 2000 times, with about 120 licenses to companies for clinical trials,” Grutkoski said.

The tool is intended for patients to self-report common factors that influence quality of life, such as shortness of breath, using a 0 to 5 scale to calculate the results that can be compared over time, with the recommended time being once every four weeks throughout the duration of a study.

“The fact that the score goes down indicates that [a patient’s] quality of life is going up,” Grutkoski said.

As part of ongoing efforts to reduce regulatory burden on both industry and agency review staff, FDA launched the voluntary MDDT program as a pilot in 2013.

In October 2017, the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) from the Mid-America Heart Institute, became the first FDA-qualified tool under the program for measuring health outcomes among patients with congestive heart failure.

Qualification of a MDDT tool “means that FDA review staff can rely on it without having to reconfirm that the tool is suitable for measuring response for the intended use, saving time and money,” FDA Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, previously said.

“MDDTs qualified by FDA can be used in clinical trials by the medical device industry to support both device submissions and post-approval studies,” Shuren added. The MDDT program also “offers developers increased opportunities to discuss early concepts of tool development, foster collaboration, and increase the potential that tools will be used and adopted.”

From device companies and developers to researchers and care providers, anyone can submit a fee-free application to propose a tool for qualification under the MDDT program. It consists of four phases—two of which are optional—and all tools fall under one of three categories—clinical outcome assessment, biomarker test or nonclinical assessment model.

FDA guidance—drafted in 2013—on the MDDT program was finalized in August 2017, with further clarifications on the three categories.

In March, Suzanne Schwartz, CDRH associate director for science and strategic partnerships, indicated FDA intends to push for a greater number of MDDT tools in the near future with different use cases.


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