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
Get Help With Insurance Buying and Renewals.
Get help buying coverage and managing renewals, with less paperwork for your team. Create your account and submit an insurance request online.
