Medical-device accounts need a product-specific review. A diagnostic test kit, durable medical equipment distributor and Class III device manufacturer may all have products exposure, but the submission package should not describe them the same way.
Begin with the device, its intended use, who uses it, the insured’s role and the regulatory context. The FDA assigns devices to Class I, II or III based on the controls needed for safety and effectiveness. Intended use and indications for use are part of that classification analysis. FDA’s classification guidance helps identify the device precisely.
Coverage questions for medical-device accounts
Products liability is one part of the review. Depending on the account, the discussion may also include general liability with products/completed operations, products-only liability, professional liability, excess liability, product recall, property, equipment or cargo.
| Question | What to identify |
|---|---|
| Product exposure | The device, intended use, user, indications, labels, warnings and territory |
| Insured’s role | Whether it designs, manufactures, imports, repairs, installs, distributes or only sells the device |
| Professional exposure | Whether the insured provides clinical, consulting, monitoring, installation, training or other professional services |
| Claims-made continuity | Current and expiring declarations, retroactive date and any prior-acts requirement |
| Excess | Every underlying policy, attachment point, aggregate and requested layer |
| Recall | Batch traceability, quality controls, complaints, notices and a written recall plan |
The FDA treats labeling broadly: it can include labels and the descriptive material accompanying a device. Its labeling overview helps explain why labels, instructions and product materials belong in a device submission.
Where a defect or withdrawal is part of the concern, use the separate product recall insurance checklist alongside the device materials.
Medical-device submission checklist
For the fastest medical-device review, include the device-specific application, labels, declarations, a website or catalog and five years of loss history. The product and requested coverage determine any additional forms.
- Completed standard application(s) and the medical-device supplemental application.
- Product catalog, website, labels, instructions for use and the device’s intended use and user.
- Exact role in the chain: design, manufacture, contract manufacture, import, repackage, distribute, repair, install or retail sale.
- Device class, regulatory status, product codes or approvals when applicable, plus the jurisdictions where the device is sold.
- Annual revenue by device or product family, sales territory, distribution channel and customer type.
- Manufacturing, quality-control, testing, complaint-handling, traceability and recall procedures.
- Five years of currently valued product and general-liability loss runs, with explanations for material, open or product-related claims.
- Current and expiring declarations, prior-insurance details and retroactive dates for claims-made coverage.
- Contracts, vendor requirements, indemnity obligations and additional-insured requirements that affect the requested limits.
- Every scheduled underlying policy and requested attachment point when excess is part of the request.
Keep products and services separate
An account can have both a product and a service exposure. Device installation, repair, patient monitoring, clinical support, software, training or consulting may create questions that a products form does not answer on its own. State the services in the opening operations narrative rather than leaving an underwriter to infer them from a website. Review professional liability separately when the service component needs its own coverage discussion.
Submit the product-specific material you have. We review the device, operations, services and coverage questions, then identify any remaining supplemental forms before approaching the market. For the cross-industry checklist, use product liability for manufacturers, importers and distributors. A complete submission improves the review; it does not establish eligibility, coverage or terms.
