Miles To Go? Case For Quality Founding Father Silverman Says Joint FDA/MDIC Initiative Isn't 'Where It Should Be'

Executive Summary

Steve Silverman – one of the original architects of the popular Case for Quality when it was launched by US FDA in 2010 – is disappointed that the initiative hasn't come further over the past eight years. "I don’t think that the Case for Quality is where it should be," Silverman, who currently is AdvaMed's VP of technology and regulatory affairs, said at a Case for Quality open forum. His blunt words came despite the momentum building behind several ongoing Case for Quality projects, including a pilot program to assess device-makers' manufacturing maturity and capability.