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# Device Makers to Get Nonbinding Feedback on Inspection Findings
- URL: https://www.fdaweb.com/device-makers-to-get-nonbinding-feedback-on-inspection-findings/
- Published: 2019-02-15T12:00:00.000Z
- Updated: 2026-09-15T01:05:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143398

FDA has issued a draft guidance on [Nonbinding Feedback After Certain FDA Inspections of Device Establishments](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM631397.pdf?ref=fdaweb.com), which proposes a process where device companies can request nonbinding agency feedback on certain kinds of documented inspectional observations that are issued on a Form 483\. The document outlines a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA will evaluate and respond to such requests.

Currently, device companies can ask for feedback on their proposed corrective actions, but there is no standardized process for providing nonbinding feedback. “Timely nonbinding feedback can help device manufacturers determine whether proposed actions to address inspectional observations are adequate, possibly avoiding taking unnecessary actions that are not likely to satisfactorily address an inspectional observation,” the agency says.

Nonbinding feedback requests, according to the guidance, must describe how one or more observations meet one or more of the statutory criteria: involve a public health priority, implicate systemic or major actions, or relate to emerging safety issues. Once requested, the agency says it intends to provide nonbinding feedback within 45 calendar days or notify the company within 45 calendar days that the request is not eligible to receive nonbinding feedback. “The FDA’s feedback should identify whether the proposed actions to address inspectional observations, if appropriately implemented, appear adequate, partially adequate or inadequate,” it says.