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

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





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

The FDA today issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations that are issued on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.  Previously, companies could ask for feedback on their proposed corrective actions, but there was no standardized process for providing nonbinding feedback. Timely nonbinding feedback can help device manufacturers determine whether proposed actions to ...