FDA Posts Draft Guidance on Requesting Nonbinding Feedback After Device Inspections
The Food and Drug Administration posted a new draft guidance document on “nonbinding feedback” provided by the agency after inspections of device establishments. The draft guidance explains how device establishments may submit requests for nonbinding feedback to FDA on actions…
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the company has proposed to take to address certain kinds of observations from FDA inspections. The document outlines a “standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests,” the agency said. Comments are due April 22.