Shawn M. Schmitt
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Latest From Shawn M. Schmitt
On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.
US FDA addressed quality systems and Medical Device Reporting violations at a manufacturer of bone fixation fastener systems in the only device-related warning letter posted this week.
BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests
When a US FDA investigator is overly familiar with a company and its people, it can lead to a weaker facility inspection that might not uncover quality system problems – which in turn could lead to troublesome devices and recalls. So says a study conducted by professors at the University of Wisconsin, Indiana University and the University of Minnesota, which found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same investigator. Even more concerning: The recall hazard shoots up 57% after an investigator's third audit of a firm. Might rotating investigator assignments help? And how might the agency's new "program alignment" inspectional scheme affect how often an investigator visits a particular firm?
Industry veteran Kwame Ulmer has cobbled together a new group to help address perceived racial disparities at device firms. "MedTech Color" has already attracted attention from heavy-hitters Johnson & Johnson, Medtronic, 3M and Danaher, as well as industry advocacy group AdvaMed.
Having trouble keeping track of the many pilot programs offered by US FDA's device center? Then this handy listing of ongoing pilots should help.
Approved by US FDA on Nov. 22, a new intraocular lens from RxSight is designed to correct residual refractive errors after cataract surgery and enable clearer vision.