Help Wanted: FDA's Office Of Regulatory Affairs Looks To Plug Investigator Vacancies, Begins 'Succession Planning'
The US FDA's Office of Regulatory Affairs – which handles all of the agency's field activities – is "sitting on a lot of vacancies right now," FDA official Jan Welch said at MedCon 2019. Here's what ORA wants to do to nab and retain staff, and plan for the next generation of senior supervisors.
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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.
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.
US Regulatory Roundup, May 2020: Quality System Reg Redo Delayed (Again); COVID-19 News; CAPA 2.0; And More
News that the US FDA missed its third self-imposed deadline for releasing a draft version of its retooled Quality System Regulation and our ongoing coverage of the coronavirus crisis captured the attention of many of our online readers last month, as did a look at a new way to conduct corrective and preventive action (CAPA) activities. Here are May’s 10 most popular US regulation and policy stories from Medtech Insight.