Vero Biotech, LLC: GENOsyl® © Delivery

We also acknowledge receipt of your amendment dated December 18, 2018, which was not reviewed for this action.

1. In prior communication, we noted your device incorporates sensory feedback for adjustment of Nitric Oxide delivery and flow rate.

These sensors and the controlled outputs © However, due to the closed-loop technology utilized in the design of the proposed device, FDA believes conformance to certain clauses of this standard will provide evidence of safety and adequate performance.

The human factors (HF) validation study, submitted on July 23, 2018, does not provide sufficient evidence to demonstrate that your proposed product can be used safely and effectively by the intended users for its intended uses and use environments.

You state that none of the changes made as part of the mitigation strategy altered the user interface or modes of use and thus no additional human factors testing is required.

We expect user performance to be evaluated using all components of the final intend-to-market user interface, including the QRG, OM, and training program, for the final intend-to-market device to provide the data to demonstrate that the mitigation strategies are effective and do not introduce new use-related risks.

We strongly encourage to you to submit your HF study protocol for the Agency's review and feedback prior to commencing your HF validation study, although such review is not a requirement.

We refer to the Paragraph IV certifications under 21 CFR 314.50(i)(1)(i)(A)(4) that you submitted in your July 23, 2018, resubmission and remind you of the requirement to amend your application to include documentation of timely sending and receipt of notice of Paragraph IV certification as described under 21 CFR 314.52(e), by each person required to receive notice.