Info Collection on Device Inspection Feedback

Federal Register notice: FDA has submitted to OMB an proposed information collection entitled “Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The collection supports a guidance under the same title that explains how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA on actions the firm has proposed to take to address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon establishment inspection completion. In response to comments received on the collection, FDA says that timely nonbinding feedback could help 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. To view the notice, click here.