CDRH Following Up More Actively On Complaints Against Device Manufacturers / FDA’s device center is using a new system to triage complaints filed against companies, with the aim of focusing on those representing the highest risk to patient safety. The system, put into use in December, “helps us eliminate complaints that are not significant enough to take action on and it helps us be more consistent with the handling of complaints,” said Ann Ferriter, director for the Division of Risk Management Operations in CDRH’s Office of Compliance. / “The Silver Sheet” January 2012

FDA District Offices Expect Specific Information From Firms When Recalls Are Initiated / Before initiating a recall, firms should first contact an FDA district office so it can review recall communications and strategies. “The district office may look at your recall strategy and find that somehow it’s inadequate, so the agency may push for you to amend it,” said Cecilia Wolyniak, an FDA recall team leader. Officials explain the types of information that should be sent to district offices. / “The Silver Sheet” January 2012

Editor’s Picks – Three Notable ‘Silver Sheet’ Stories From 2011 / Top stories of 2011. “Silver Sheet” readers were most interested in recalls, an FDA plan to boost device quality and process validation tips. / “The Silver Sheet” January 2012

FDA Warning Letters / QS and MDR reg violations identified at manufacturer of LED surgical lamps; CooperVision cited for problems with contact lens labeling. / “The Silver Sheet” January 2012

FDA Close-Out Letters / Close-out letters released by the agency from Dec. 13 through Jan. 9. / “The Silver Sheet” January 2012

News In Brief / FDA orders makers of surgical mesh and mini-slings to conduct Sec. 522 post-market studies; agency aims to make guidance development process more transparent. / “The Silver Sheet” January 2012