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# Nonbinding Feedback Guidance
- URL: https://www.fdaweb.com/nonbinding-feedback-guidance/
- Published: 2020-04-21T12:00:00.000Z
- Updated: 2026-09-14T16:11:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146607

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](https://www.fda.gov/media/120260/download?ref=fdaweb.com) 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.