Should I describe my lab and diagnostic product separately?
Yes. A lab may perform testing and report results while another part of the business develops or sells an assay or instrument. FDA treats an IVD as a product with a specific intended use, so list the service and each product separately for the quote.[2]
For each lab service, identify specimen types, who interprets results, customers, and locations. CMS’s CLIA guide ties certificate application to the facility’s actual testing activity and describes limited exceptions.[1]
For each product, identify intended use, design or manufacturing role, stage, and sales channel. Ask the broker to show how the proposed terms address the lab service and product separately.[2][3]
Read the Diagnostics Insurance Buying Guide
Sources and Further Reading
- Getting Started with CLIA — Centers for Medicare & Medicaid Services. Opening CLIA certificate application statement and listed exceptions
Check whether the lab’s actual human-specimen testing activity is described in CMS’s CLIA guidance.
- Overview of IVD Regulation — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding
Describe an assay or instrument by intended use and product role when preparing the application.
- Medical Malpractice Insurance — National Association of Insurance Commissioners. Background: medical professional liability scope
- Guidance on HIPAA & Cloud Computing — U.S. Department of Health and Human Services, Office for Civil Rights. Questions 1–3 on covered entities, business associates, and cloud services
- 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; boiler and machinery; commercial general liability
Review the guide’s general property and machinery topics, then confirm terms in your proposed forms.
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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