FDA’s Final Device Establishment Inspections Guidance Misses the Mark

April 23, 2020By Rachael E. Hunt

While it seems like all of FDA is consumed with responding to the current COVID-19 crisis, the agency is still managing to continue its work in other areas.  Earlier this week, FDA issued a final guidance, titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection.  Notably, the final version of the guidance is essentially the same as the draft issued on February 19, 2019, which we blogged about here.

Specifically, the final guidance does nothing to address the concern we raised in our prior post: this program creates a lose-lose situation for industry.  While the admissions could be used in an enforcement action or a products liability lawsuit to demonstrate knowledge of a problem, a failure to request available feedback could be used to show negligence or willful ignorance of the same.  But even in requesting such feedback, FDA acknowledges that it “may not adequately address the cause of the problems that led to the inspectional observations, and additional action may be warranted.”  FDA, Guidance for Industry, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, 8 (April 22, 2020).  Nor does FDA’s feedback prevent additional observations or regulatory action.  Ultimately this guidance does little to create an effective method of gaining feedback from FDA.