In an effort to address safety and quality issues emerged during medical device establishment inspections as quickly and adequately as possible, on February 19, 2019, the US FDA issued a draft guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, in compliance with section 702 “Improvements to inspections process for device establishments” of the FDA Reauthorization Act of 2017 (FDARA).
The draft guidance proposes a standardized process through which stakeholders (“owner, operator or agent in charge” of the device establishment) can request nonbinding feedback on the observations documented on the Inspectional Observations Form (Form FDA 483), released by the FDA upon completion of a premarket and/or postmarket device establishment inspection.
The submission of the request for nonbinding feedback is to be made “in a timely manner”, within 15 business days after Form 483 is issued. FDA intends to provide its response within 45 calendar days or notify the company within that time if the request is not eligible for the feedback.
Stakeholders are invited to submit their comments and opinions on the matter until April 20, 2019.