FDA requests public comments on the draft guidance, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"

FDA requests public comments on the draft guidance, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments." which was part of the FDA Reauthorization Act of 2017 (FDARA). This draft guidance proposes a method for medical device manufacturers to request nonbinding feedback from the FDA in response to certain kinds of observations the FDA may document during an inspection of the device establishment that are issued on a Form 483.  The guidance also outlines statutory criteria for being eligible for this feedback.

The FDA believes that timely, nonbinding feedback can help device manufacturers determine whether their proposed actions to address inspectional observations are adequate, possibly avoiding unnecessary investment on potential solutions not likely to satisfactorily address an inspectional observation. 

This guidance is draft and not for implementation at this time. 

The FDA encourages industry and other stakeholders to review the draft guidance and to provide comments.  The comment period will be open for 60 days in the Federal Register under docket number FDA-2018-D-4711, starting February 19, 2019. 

Questions?
If you have questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.