ISSUE: Clinical evidence available at market authorization for medical devices is not meeting the needs of hospital payers and providers. As a result, HTA bodies and clinical groups are now looking to incorporate other forms of evidence, including real world data, into their assessment processes. Questions are arising as to what evidence should be include, who should produce and fund the research, and who has ownership of the evidence. Karen Worley will moderate, providing a brief overview of the issue. Bruce Gingles will address the current evidence production system through the manufacturer lens. Suzanne Belinson will address payer needs when evaluating coverage options. Harindra Wijeysundera will address the state of currently available evidence for devices and how observed gaps impede evaluation. OVERVIEW: Medical devices are regulated and reviewed in a manner different from pharmaceuticals. In the US, devices typically progress through an FDA clearance, providing data demonstrating that the new device is “substantially equivalent” to a device on the market, rather than an approval process, resulting in a paucity of clinical data in all phases of a technology’s life cycle. Where research does exist, published studies are highly variable in design and outcome evaluation. Standardization of clinical and economic research for medical devices could potentially be very beneficial for payers, providers, and HTA bodies, but there is no consensus as to who should oversee such an initiative. This panel will discuss the importance of standardization of clinical evidence for devices and debate the question of who should be sponsoring and directing such a standardization process. Organized by the ISPOR Health Technology Assessment – Pharmacy and Therapeutics (HTA-P&T) Roundtable – North America