Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments

FDA issued the draft guidance document “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding 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 completion of an inspection of the firm’s establishment. This information collection request identifies the estimated burden of submitting requests for nonbinding feedback to FDA.

The latest form for Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments expires 2023-04-30 and can be found here.