> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Changes Suggested for Device Inspection Feedback Guidance
- URL: https://www.fdaweb.com/changes-suggested-for-device-inspection-feedback-guidance/
- Published: 2019-04-24T12:00:00.000Z
- Updated: 2026-09-15T01:22:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143948

AdvaMed says that while it appreciates FDA publication of a draft guidance on non-binding feedback after certain FDA medical device establishment inspections, the draft does not satisfactorily deliver the result that is sought — using agency feedback on remediation of inspectional observations to assure that the remediation effectively and efficiently resolves quality system deviations. In particular, the association comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-D-4711-0005&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says, the 15-day deadline for feedback requests is too short. And it says the draft “sets overly-narrow eligibility criteria that preclude feedback requests that are appropriate and contemplated by FDA Reauthorization Act Section 702.”

The letter asks the agency to: **(1)** extend the deadline for feedback requests to 45 days after a manufacturer determines the need to address an inspectional observation; and **(2)** broaden its interpretation of the criteria for non-binding feedback.