FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment.

The draft guidance, released in response to the FDA Reauthorization Act of 2017 (FDARA), proposes a pathway for device and biologics manufacturers (regulated under device authorities) to receive nonbinding feedback on some or all of their proposed corrective action plans in their response to FDA Form 483 (Form 483) inspectional observations. This process, if implemented as described in the draft guidance, should be carefully evaluated depending on the circumstances, as discussed below.

Read More: FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483


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