FDA Focuses on Management for Quality Lapses

An FDA Center for Device and Radiological Health (CDRH) official recently announced increased scrutiny of management oversight for device and diagnostic manufacturing companies. In a presentation delivered June 20, Casper Uldriks, Special Assistant to the CDRH Compliance Director, reported a new approach to enforcement actions that will hold management more accountable for quality system failures.

Managing Partner Colleen Hittle Densmore observes that “In our consulting practice we have seen a growing FDA focus on management responsibility for some time. The time impact and distractions can be quite significant. Anson has developed its corporate compliance risk assessment and risk management services specifically to help our clients to cope with this trend.”

The FDA’s new focus derives from the authority of federal legislation making medical device company executives responsible for establishing and providing resources for an adequate quality system with defined goals and regularly reviewing its performance to assure compliance (CFR 21, Part 820.20). FDA has been interpreting this requirement to make senior management more directly accountable for the adequacy of corporate compliance systems.