viernes, 27 de octubre de 2017
FDA qualifies first tool under Medical Device Development Tools (MDDT) program
The FDA is excited to announce that we have qualified the first tool under the medical device development tools (MDDT) program, a voluntary process intended to reduce regulatory burden for medical device developers and FDA reviewers through the qualification of tools that can aid in the development and evaluation of medical devices.
MDDTs qualified by the FDA can be used by the medical device industry to support device submissions, which could reduce time and other resources involved in product development. FDA qualification of an MDDT is different from FDA clearance or approval of a medical device. The type of evidence needed to support MDDT qualification is not the type of evidence that is needed to support marketing authorization for a medical device.
The first qualified tool, the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ), 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. The KCCQ may be a particularly useful tool for sponsors and developers of devices designed to address heart failure.
The KCCQ has been used already by researchers, clinicians, and medical device developers for around 20 years. FDA qualification of the KCCQ goes a step further. Now, manufacturers and sponsors do not have to justify their use of the tool within a specific context of use, and FDA review staff can accept the use of the tool without the need to reconfirm its suitability and utility. 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 KCCQ is a patient-reported outcome (PRO) tool, and was qualified under the clinical outcomes assessment tool category, which are subjective or objective measures of how a patient feels or functions. 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.
More information about the KCCQ is available on the FDA’s Medical Device Development Tools webpage. Additional tools will be added to this webpage once they are qualified.
Additional information about the MDDT program, including other types of MDDTs, is available in the FDA Voice blog post
"Medical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval".
Center for Devices and Radiological Health
Food and Drug Administration