FDA Seeks Coverage Organization Input on Device Trial Design

Federal Register Notice: FDA is requesting expressions of interest from organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These coverage organizations include third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups and various organizations that evaluate clinical evidence and make coverage recommendations to and decisions for private payers and health plans. CDRH is taking this step to assist sponsors in identifying such organizations and soliciting clinical trial design or other evidence-gathering input from them. To view this notice, click here.