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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA is issuing this draft guidance document to comply with section 702 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 704 of the Federal Food, Drug,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 The purpose of this draft guidance is to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding actions the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 This draft guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-4711.