Thursday, 2 July 2020 14.00 - 15.30 h
In "FDA Feedback after an Inspection at a Medical Device Manufacturer" you could already read about an FDA draft guideline which describes (non-binding) feedback after an FDA inspection of a medical device manufacturer. This guideline has now been finalized and was released in April 2020. What changes have been made?
Actually, not many changes have been made. There is strong reference to the FDA Reauthorization Act (FDARA) Section 702. It requires the FDA to improve its inspection process by providing feedback on announced corrective actions by the inspected company. It is now also possible to respond to requests for non-regulatory guidance. This is explained in a footnote.
The scope has remained the same with eight pages. The request for feedback should still be submitted within 15 days, comparable to the reply to the Form FDA 483. The request should come from the person to whom the Form 483 was also addressed. Alternatively, someone who can show that he or she can act responsibly for the company inspected - such as a managing director - can also make the request. The FDA then replies within 45 days.
For further information please also see the finalised guideline entitled "Nonbinding Feedback After Certain FDA Inspections of Device Establishments - Guidance for Industry and Food and Drug Administration Staff".