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.
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 for Diagnostics
- 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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