Device manufacturers will have an opportunity to sit down with the FDA to hear its perspective on the Quality Metrics Initiative during the Case for Quality Public Forum Oct. 26.
The Medical Device Innovation Consortium working groups will present information on the work they have done so far and what the future plans are.
“We’re trying to foster a new culture of quality by identifying, developing, disseminating and embracing evidence-based critical-to quality practices throughout the entire product lifecycle,” Dwight Abouhalkah, program manager for the Case for Quality, told IDDM.
The metrics group unveiled findings from its pilot study in June, and the group has been engaged with sharing information with the FDA’s Center for Devices and Radiological Health. The FDA plans to unveil its own quality metrics initiative, and devicemakers will have an opportunity to hear more about those plans at the forum (IDDM, Aug. 12).
By engaging in these collaborative forums, device manufacturers are able to form better relationships with the FDA, and “we’re finding that we are able to influence the agency more than we have been able to in the past.”
For more information, visit: www.fdanews.com/09-07-16-MDICforum.pdf. — Tamra Sami