FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff.  This guidance was issued on April 22, 2020.  The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are adequate, possibly avoiding unnecessary investment in potential solutions not likely to satisfactorily address an inspectional observation.”  There certainly might be situations where this guidance may prove useful to medical device manufacturers.

SoftwareCPR advises caution is using this approach.  Avoid rapid reaction to inspectional feedback and creating more problems moving forward.  All audit and inspectional feedback should be carefully analyzed to understand the quality management system as a whole.  Rarely is a finding localized to a single process … most often it involves many processes and often points to higher level management messages (or lack of).  Take the time to talk with everyone that has a role in the process and LISTEN.  Create venues where people are enabled to talk freely and openly about the processes.  Look for underlying themes … could it be that the processes are actually negatively affecting product quality?  Could people have been put into roles without adequate training?

Take the time to carefully consider changes and avoid patching processes.  Go back and build a more lean and optimized process.

You can download the draft guidance here:  Nonbinding Feedback After Certain FDA Inspections of Device Establishments Guidance for Industry and Food and Drug Administration Staff