Does FDA device status tell me what my insurance covers?
No. FDA guidance helps describe the device, intended use, and product stage. Ask the broker to identify the forms and exclusions relevant to a claim, recall expense, or customer contract requirement.
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 for Medical Devices
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