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GUIDANCE DOCUMENT

Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments Guidance for Industry and Food and Drug Administration Staff February 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments

Docket Number:
FDA-2018-D-4711
Issued by:
Guidance Issuing Office
Center 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FDA is issuing this draft guidance document to comply with section 702 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 704 of the Federal Food, Drug,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 The purpose of this draft guidance is to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding actions the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 This draft guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such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.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.