Monday, January 13, 2014

CDRH’s 2014 Enforcement Strategy – Less Talk, More Action, Says Steven Silverman

CDRH’s 2014 Enforcement Strategy – Less Talk, More Action, Says Steven Silverman-thegrahsheet: Steven Silverman, who directs CDRH’s Office of Compliance, says this year he wants to translate his recent focus on better collaboration with manufacturers into more tangible actions that improve device design and quality. The center recently unveiled several pilot programs, set to get off the ground this year, with that goal in mind. The Voluntary Compliance Improvement Pilot will give manufacturers at risk of enforcement actions due to regulatory violations an opportunity to identify and self-correct the violations