Changes Suggested for Device Inspection Feedback Guidance

AdvaMed says that while it appreciates FDA publication of a draft guidance on non-binding feedback after certain FDA medical device establishment inspections, the draft does not satisfactorily deliver the result that is sought — using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 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.