Nonbinding Feedback Guidance

FDA has issued a final guidance, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, to explain how an owner, operator, or agent in charge of a medical device establishment may submit a request for nonbinding feedback to FDA about actions the firm proposes to take to address certain kinds of inspectional observations documented on an FDA-483 and issued to the firm after completion of an inspection of the firm’s establishment. The document gives a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.

Guidance contents are Introduction, Background, Submitting a Timely Request for Nonbinding Feedback, Statutory Eligibility Criteria for Nonbinding Feedback, Justification of Request, Proposed Responsive Actions, Nonbinding Feedback, and Paperwork Reduction Act of 1995.