CDRH to Highlight Risk-Assessment Priorities This Week

The Center for Devices and Radiological Health (CDRH) is continuing its efforts to use information from other healthcare regulators to enhance its risk assessments of manufacturing facilities, according to an FDA director.

Timothy Ulatowski, director of CDRH’s Office of Compliance, will detail the center’s priorities, including its work to recalibrate the FDA’s Office of Regulatory Affairs risk-based surveillance priorities, at the upcoming Fifth Annual Medical Device Quality Congress June 25–27 in Cambridge, Mass.
 
The changing regulatory environment, increased harmonization with foreign regulators and implementation of CDRH initiatives will be discussed. Ulatowski will outline the FDA’s medical device facility inspections program and advise manufacturers of situations when they might be audited.

Also at the conference, Steven Niedelman, vice president of Quintiles Consulting and former FDA deputy associate commissioner for regulatory operations, will discuss how firms can best operate supplier control programs. He will explain the importance of tight agreements with contractors and the ways quality systems regulations address procurement issues.
                           
Julie Fraser, president of IT consultancy Cambashi, will present results from a survey of devicemakers on best practices for risk management. The survey found that investments in design controls and root cause analysis are the top areas companies focus on to reduce business risk.