Risk Management Checklist for Safety Information for Home-Use Products

Home-use products have been increasingly utilized by patients to improve their quality of life and to allow them greater independence. The increase in demand for home-use devices has been attributed to the United States’ aging population and exacerbated by the COVID-19 pandemic. Medical technology and life sciences manufacturers have had to convert products typically used in a clinical setting into products for use by patients at home, without the direct assistance of a healthcare provider. This change in intended user alters the products liability risk profile of these products in several ways, particularly with regard to safety information. It is easier to write safety information for healthcare providers who share a common educational background than for members of the general public.

This checklist provides general guidance for manufacturers related to developing labels, warnings, and instructions for home-use products and avoiding common problems that can lead to warning defect claims.