FDA Issues Final Guidance on Nonbinding Feedback After FDA Inspections of Device Establishments

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Nonbinding Feedback After Certain FDA Inspections of Device Establishments. The guidance explains how an owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to the FDA about the corrective actions they propose to take to address certain kinds of inspectional observations documented by the FDA during an inspection.

Timely resolution of inspectional observations is important to continued availability of safe and effective devices in the U.S. market. Timely nonbinding feedback can help support quicker resolution of the FDA’s inspectional observations, possibly avoiding the investment of unnecessary time and resources on ineffective solutions. This guidance is mandated by section 702 of the FDA Reauthorization Act (FDARA) of 2017.

Read the Guidance