Abstract
Real-world data (RWD) collected to generate real-world evidence (RWE) holds promise for expediting patient and healthcare provider access to new in vitro diagnostics (IVDs) by serving as evidence to demonstrate test performance or utility. However, uncertainties remain for IVD developers (device manufacturers), regulators, and other healthcare stakeholders on the specifics of collecting fit-for-purpose RWD and using RWE for regulatory decision-making. We report on a unique approach to medical device regulatory review called the Open Hand Initiative, by which the US Food and Drug Administration (FDA) and device manufacturers collaborate to ensure the appropriate use of RWD/RWE to support regulatory decision-making. Normally, regulatory submission interactions are confidential; in the Open Hand approach, device manufacturers share high-level learnings from pre-submission interactions to advance the use of reliable and relevant RWD/RWE for regulatory decision-making. In a pilot study, the Open Hand approach was applied to pre-submission interactions regarding the use of RWD/RWE for transition of SARS-CoV-2 serology IVDs with Emergency Use Authorization (EUA) to full market authorization. Participants in the pilot agreed that the candid discussions were key to identifying barriers to efficient, timely, and robust RWE generation for IVD premarket submissions. The pilot also led to valuable lessons learned around current regulatory requirements for RWE, SARS-CoV-2 testing complexities, and the impact that the rapidly evolving COVID-19 pandemic had on RWD availability and quality. The Open Hand Initiative can be applied more broadly to guide device manufacturers in collecting high-quality RWD to generate RWE for premarket applications.