FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 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,” FDA said in an email statement.
“Finding those accurate, efficient, and reliable tools can be challenging, especially given the diversity of technology and of medical devices. That’s where FDA’s voluntary Medical Device Development Tools (MDDT) program can help,” says Hilda F. Scharen, director of Medical Device Development Tools at FDA’s CDRH, and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health in FDA’s blog.
“FDA can evaluate a tool and decide whether to “qualify” it — which means we can determine if the tool measures what it’s supposed to measure, and does so reliably,” say Scharen and Shuren.
The blog notes that FDA intends to qualify tools only in cases where the agency can determine that high-level information about the tools is publicly available to ensure that the device development community can benefit from using tools that the agency knows will work.
In August FDA released its final guidance, which describes how it will 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. FDA stresses that FDA qualification of an MDDT is not the same as FDA clearance or approval of a medical device, and that qualification relies on different types of evidence.
“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,” Scharen and Shuren note in their blog.
FDA says that the MDDTs it qualifies can be used in clinical trials by the medical device industry “to support both device submissions and postapproval studies.” But they say that the program’s impact goes much further by offering developers “increased opportunities to discuss early concepts of tool development, foster collaboration, and increase the potential that tools will be used and adopted.”
Editor and Director of Medical Content
Note: The guidance doc can be found here .