FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations


The FDA recently issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations that are issued on a Form 483, during either premarket or postmarket inspections of device establishments. It identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how the FDA evaluates and responds to such requests.

See Full FDA Posting Here: https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm631475.htm