The FDA guide “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” explains how an owner, operator or agent responsible for a medical device company may submit a non-binding feedback request to the FDA with regard to corrective actions to address certain types of inspection observations documented on form 483 by the FDA.

FDA guide on non-binding feedback request after inspection
FDA guide on non-binding feedback request after inspection

What inspection observations may meet the legal criteria for non-binding feedback?

Timely resolution of inspection observations is important for the continuous availability of safe and effective devices in the US market. A timely and non-binding feedback may contribute for a faster resolution to the FDA inspection observations. This guide is required by section 702 of the FDA Reauthorization Act (FDARA) of 2017 which amended section 704 of the Food, Drug and Cosmetic Act (FDCA). Particularly, this section states that the request shall describe how one or more observations “involve a public health authority”, “involve systemic or important actions” or “relate to emerging security issues”. FDA provides the following examples of observations that may meet the legal criteria for non-binding feedback:

  • An observation relating to conditions, which, if not addressed, may result in the release of a violent product that may cause death or serious injury;
  • An observation concerning deficiencies in the quality system or subsystem that have or may involve a non-compliant, violative and/or defective device;
  • An observation relating to an emerging security problem that, if not solved, may result in the release of devices which could cause death or serious injury.

Non-binding feedback request and FDA response

The non-binding feedback request must be sent within 15 working days after the issuance of form 483 and it must be addressed to the FDA contact responsible for receiving any response to FDA form 483. The request must indicate the inspection observation for which feedback has been requested, as well as the corrective actions proposed.  

After receiving an application, FDA will first determine whether the eligibility criteria are met. Otherwise, within 45 days, FDA will inform the applicant that the application is not admissible. If the request meets one of the criteria, FDA is required to provide a non-bending feedback within 45 calendar days.

Through the feedback, FDA will communicate whether the proposed corrective actions appear adequate, and, if not, it must provide explanations to enable corrective actions to be properly carried out.

The FDA feedback does not prevent further regulatory comments or actions. Companies are not required to adhere to the non-binding feedback provided by FDA; they may, in fact, use an alternative approach to correct inspection observations.

Thema offers services of strategic-regulatory consultancy to companies producing or distributing Medici and IVD devices.
Contact us for more information