'Program Alignment' Snaps Together: What's Next For US FDA's Inspection Scheme
Almost six months into its new "program alignment" inspection approach, FDA's initiative to inspect along commodity lines is still gaining its sea legs. A key FDA official says the agency is taking steps to train and retain specialized investigators. Meanwhile, FDA wants to use a geographic information system (GIS) tool to keep tabs on where investigators are inspecting.
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'Program Alignment' Turns 1: FDA Wants To Train Investigators On Innovative Tech As Part Of Its Inspection Scheme – But Will It Be A Cakewalk?
At the one-year anniversary of "program alignment" – US FDA's ambitious reorganization of its inspectional body – the agency is pushing hard to train its investigators on an array of medtech products. In that spirit, FDA has asked manufacturers to willingly open their doors to its investigators so they can learn more about the type of devices the firms are making, says Blake Bevill, a program division director for program alignment. Industry group AdvaMed and health-care organization Medical Alley Association are also getting in on the action by helping investigators learn about an array of topics, including software, electrical engineering, validation and design.
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?
In its continuing bid to better understand how industry and other stakeholders operate in the real world and learn to improve its own practices, FDA is again asking volunteers to let staffers come observe organizations for a day or two as part of the device center's Experiential Learning Program.