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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?

 
• By Shawn M. Schmitt

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.

Birthday Cake first b'day

After a full year of growing pains for US FDA's "program alignment" inspectional reorganization, it appears to be gaining its sea legs. And now the agency has reached out to device-makers and industry groups to help educate investigators about hot topics such as software, electrical engineering, validation, design, and more.

Launched on May 15, 2017, program alignment was the most sweeping change to FDA's inspectional approach in agency history. Under the scheme, inspections performed by FDA's Office of Regulatory...

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