This document provides guidance to industry and FDA staff on the purpose and content of a userelated risk analysis2(URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product3 19 development and to support a marketing application.
This guidance applies to drug- and biologic-led combination products that include a device constituent part and are the subject of an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA) and supplements to these applications.
In certain cases, this guidance may also apply to the following stand-alone drug and biological products (i.e., those that are not part of a combination product):
• Human prescription drug products, including biological products, that are the subject of an IND, NDA, or BLA and supplements to these applications
• Human nonprescription drug products that are the subject of an IND or NDA, and supplements to these applications
All such products in this guidance are jointly referred to as products, and those responsible for making submissions are referred to as sponsors or applicants.7