FDA has issued the guidance document Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff.
FDA is issuing this guidance document to comply with section 702 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The purpose of this guidance is 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 guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.
Read more from the FDA and find the text of the document here.
