Background: As digital and computational pathology become increasingly integrated into clinical practice, the Pathology Innovation Collaborative Community (PIcc), convened by the Medical Device Innovation Consortium (MDIC), recognizes the critical importance of regulatory science in this evolving landscape. We propose a focused session at the 2024 Visions meeting to foster collaborative dialogue on regulatory topics within digital pathology, specifically addressing its adoption in the USA.Introduction: This session aims to facilitate dialogue among stakeholders from industry, academia, and regulatory agencies to address key regulatory challenges and opportunities in adopting digital pathology in the USA. Leveraging diverse expertise, we seek to advance regulatory science and accelerate the development and adoption of innovative medical devices in pathology.Session Objectives: - Provide an overview of current regulatory advances and challenges in digital pathology adoption in the USA. - Discuss the results of the PIcc regulatory landscape survey and gather audience input through a digital survey. - Highlight the role of PIcc in advancing regulatory science and fostering industry-academia-regulatory partnerships. - Share insights from regulatory agencies, including the FDA, on regulatory considerations for digital pathology technologies.Session Format: The session will include short impulse talks by representatives from PIcc, MDIC, regulatory agencies (e.g., FDA), and industry stakeholders, followed by a panel discussion. Talks will cover specific regulatory challenges, innovative approaches, and collaborative initiatives in digital pathology.Interactive Component: A digital survey will be used to gather real-time audience input on key regulatory issues and broader community needs, enhancing engagement and inclusivity.Specific Focus: The session will focus on '<em>Taking the First Steps to Digital Pathology Adoption in the USA</em>,' including understanding rules and regulatory precedents. It will also address the results of the PIcc regulatory landscape survey.Benefits of Participation: - Gain insights into current regulatory trends and challenges in digital pathology adoption. - Network with key stakeholders from industry, academia, and regulatory agencies. - Contribute to the advancement of regulatory science and development of innovative medical devices. - Enhance visibility and recognition within the pathology community through oral presentation and abstract publication in the Journal of Pathology Informatics. - Participate in an interactive digital survey to provide real-time input on critical issues, ensuring inclusivity and capturing a wide range of perspectives.Conclusion: This session represents a collaborative effort to address critical regulatory issues in digital pathology adoption, leveraging the results of the PIcc regulatory landscape survey. By engaging diverse stakeholders, we aim to drive progress in regulatory science and improve patient care through innovative technologies.

Learning Objectives

1. Provide an overview of current regulatory advances and challenges in digital pathology adoption in the USA. Discuss the results of the PIcc regulatory landscape survey and gather audience input through a digital survey.  
2. Highlight the role of PIcc in advancing regulatory science and fostering industry-academia-regulatory partnerships.
3. Share insights from regulatory agencies, including the FDA, on regulatory considerations for digital pathology technologies.