FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says

CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative – which aims to create an ongoing culture of quality at medical device manufacturers. According to CDRH Office of Compliance Director Steven Silverman, the forums are the next step in the initiative, which is similar to the agency’s Quality by Design initiative for drug manufacturers. He spoke Thursday at FDAnews’ Ninth Annual Device Quality Congress in Bethesda, Md.
Devices & Diagnostics Letter