Threshold Analyses for Combination Products and Medical Devices

Threshold analyses are detailed comparisons between the user interfaces of two products to identify and assess the potential impact of any differences. The United States (US) Food and Drug Administration (FDA) first introduced the concept of threshold analyses in two draft guidance documents released in January 2017 by the Center for Drug Evaluation and Research (CDER). While threshold analyses were initially introduced in the context of generic and interchangeable biological combination products (i.e., drug delivery devices), aspects of the method also apply to medical device development.

Members of Emergo by UL's Human Factors Research & Design division offer insights in this white paper regarding when and how to perform threshold analyses, along with a series of accompanying considerations.