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

Article preview from "The Gray Sheet"- January 13, 2014

In an interview with “The Gray Sheet,” CDRH Office of Compliance Director Steven Silverman detailed upcoming pilot programs designed to translate his recent focus on agency-company collaborations into action.

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

Article preview from "The Gray Sheet"- January 13, 2014

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. 

Another upcoming pilot will focus on implantable devices with batteries to identify “critical-to-quality” factors that are most likely to cause quality problems in order to provide for more focused inspections. (See "New FDA Pilot Program To Identify ‘Critical-To-Quality’ Points" — "The Gray Sheet," Nov. 25, 2013.) The program is part of the center’s Case for Quality initiative, which launched in 2011 and aims to foster medical device quality through agency and stakeholder collaborations. 

In an interview with “The Gray Sheet,” Silverman said his office will begin contacting companies to participate in both pilots this month. He also hinted at a third potential pilot program for 2014 focused on prioritizing observations made at manufacturing facility inspections.

Silverman further discussed how the upcoming pilots fit into FDA’s goal of engaging more collaboratively with stakeholders and announced plans to develop more forums to facilitate ongoing discussions on device quality-related topics. Below are excerpts from the discussion.

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