Open Hand
Overview
The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an interactive review session and share learnings between sponsors to advance the understanding of fit-for-purpose RWD to generate RWE.
The Open Hand Initiative: Facilitating the Use of RWE
The Open Hand Initiative, led by MDIC in collaboration with the FDA and industry partners, showcases a groundbreaking approach to using real-world data (RWD) and real-world evidence (RWE) in regulatory submissions. Piloted during the COVID-19 pandemic, this initiative brought together stakeholders to openly share insights and address challenges in transitioning SARS-CoV-2 diagnostics from Emergency Use Authorization (EUA) to full FDA approval.
By fostering transparency and collaboration, the Open Hand Initiative highlights best practices for leveraging high-quality RWD to generate RWE and streamline regulatory decision-making. Discover how this innovative model is shaping the future of medical device approvals and advancing patient care.
Open Hand Working Group
Active Open Hand Working Group members represent the following IVD stakeholders:
- Becton Dickinson
- Roche
- Siemens-Healthineers