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.
For additional resources, contact the Marketing department
Phone: 888-633-6272
TDC Specialty is the marketing name for the specialty insurance operations and services of The Doctors Company and its subsidiaries and affiliated companies, including TDC Specialty Underwriters, Inc., TDC Specialty Insurance Company, TDC National Assurance Company, Healthcare Risk Advisors, Inc., Hospitals Insurance Company, Inc., ProAssurance Specialty Insurance Company, and Medmarc Casualty Insurance Company. All products and services are written or provided by subsidiaries or affiliates of The Doctors Company. The Doctors Company does not underwrite excess and surplus lines insurance. Certain coverages may be provided through surplus lines insurance subsidiaries of The Doctors Company through licensed surplus lines brokers. Coverages may be underwritten by TDC Specialty Insurance Company, TDC National Assurance Company, Hospitals Insurance Company, Inc., ProAssurance Specialty Insurance Company or Medmarc Casualty Insurance Company, all wholly owned subsidiaries of The Doctors Company. Product summaries are for informational purposes only. Coverage is subject to the language of the policy as actually issued. Coverage, policy terms, and availability may vary by state.
TDC Specialty Underwriters, Inc., is based and domiciled in Connecticut; in California d/b/a Insurance City Solutions (license #0L85833) and in New York, d/b/a TDC Specialty Underwriters Services. Healthcare Risk Advisors, Inc., is based and domiciled in New York.
Copyright © 2026 - Medmarc