Ask the broker to show the product-liability wording and any relevant exclusion or limit for the allegation you are considering.[6]
Read the Medical Devices Insurance Buying Guide
Sources and Further Reading
- Quality Management System Regulation (QMSR) — U.S. Food and Drug Administration. Effective-date statement; Applicability of the QMSR; CGMP Exemptions
Confirm the stated finished-device manufacturer scope when describing your product stage; it does not determine insurance response.
- Overview of IVD Regulation — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding
Describe an in-vitro diagnostic product and its intended use when it is part of your device.
- Cybersecurity — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification
- Cyber Insurance: Cybersecurity for Small Business — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
- Commercial Insurance Guide — California Department of Insurance. Commercial property; inland marine; boiler and machinery; commercial general liability
Review California guidance on business property, liability, and movable property; compare it with the policy form.
- Small Business Insurance — National Association of Insurance Commissioners. General liability, products, and other business liability sections
Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.
Updated 2026-09-28. Editorial Policy
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