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

May 25, 2012

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.

One important goal of the Case for Quality is that it seeks to encourage devicemakers to implement strong quality systems — based on industry best-practices — rather than reactively waiting for deficiencies to be discovered during inspection.

The specifics of the program are still coming into focus, but the reasons behind it are clear. The FDA continues to see a “consistently high volume” of the same quality shortcomings year after year, and 2011 was a record year for inspections classified as “Official Action Indicated,” which denotes a severity of concern, he said.

The FDA is aggressively pursuing tighter controls for preapproval inspections, supplier quality management, cGMPs and everything else under the sun.

Be ready for anything the FDA might throw at you. Mark your calendar for the Seventh Annual FDA Inspections Summit this Sept. 19-21 in Bethesda, Md.