Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01)

The primary objective of the original RFA-FD-15-002 funding opportunity was to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission. One specific area of collaboration is to enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions.The scope of this area of collaboration is being expanded to support an international, collaborative portal for sharing and analyzing medical device information, including audits of device manufacturers and assessments of auditing organizations. Additionally, this development should ensure effective, traceable, and secure information exchanges among intended participants and be scalable to accommodate existing and future needs and conform to appropriate data transmission standards.