AbbVie Inc.: AGN-151586

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on FDA Form 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

®() listed in this application, FDA conveyed deficiencies to the representative of the facility.

FDA office indicated on the FDA 483 prior to your complete response.

Submit draft carton and container labeling revised, based on our recommendations noted below under Additional Comments, when you respond to the application deficiencies.

We recommend the following be implemented for the carton labeling, container labels, and the Instructions for Use for Vyalev:

Per 21 CFR 208.24(d), the label of each container or package, where the container label is too small, of drug product for which a MG is required under this part shall instruct the authorized dispenser to provide a MG to each patient to whom the drug product is dispensed, and shall state how the MG is provided.

FDA recommends the labeling describe any factors that may affect flow accuracy such as ambient temperature, fluid temperature, pressure (e.g., head height, backpressure, atmospheric pressure), fluid viscosity, or changes in flow rate or bolus delivery (e.g., such as when titrating medications).

Please note, some of the recommended factors may be included in the labeling and/or are inapplicable; however, the labeling for Vyafuser does not include information regarding head height or backpressure.

EPRs are essential design inputs and outputs critical to achieving the intended use of the device which, in this case, is successful delivery of the drug product as identified by AbbVie.

The comments in this section are not intended to convey human factors (HF) approvability issues with your proposed product; however, it will be necessary for you to consider how any revisions to your proposed product to address the deficiencies outlined above will impact your user interface.

If your user interface is revised in response to the CR, you should update your use-related risk analysis (URRA) to determine whether any new risks, including new critical tasks or failure modes are introduced by the changes.

We strongly recommend you submit this information to the Agency for review prior to resubmitting NDA 216962 to ensure the Agency agrees with your determination regarding the HF data need to support your revised user interface.

If you determine that you do need to submit the results of an additional HF validation study for your revised user interface, we recommend you submit your study protocol for feedback from the Agency before commencing your study and prior to resubmitting NDA 216962. Note that submission of a protocol for review is not a requirement.