CDRH actively exchanges information with international regulatory counterparts to support the agency’s global engagement strategic priority.
Training through Regulatory Capacity Building
CDRH offers web based training modules through CDRH Learn to offer FDA employees, foreign regulators, and industry training to ensure that all parties are aware of current policies and procedures. In addition, several of the CDRH Learn modules are available in Mandarin Chinese and Spanish to address international stakeholders’ needs.
Government to Government Exchange
Through CDRH’s International Program, regulatory information of mutual interest is exchanged with foreign regulatory counterparts. CDRH can exchange information that is publicly available, as well as information of a confidential nature when conducted under the U.S. FDA’s Confidentiality Commitments. This exchange allows regulators to leverage resources, aggregate data, and share information for better informed regulatory policies and decisions.
CDRH also undertakes a number of structured scientific and policy discussions with foreign regulatory counterparts, such as trilateral scientific calls with medical device subject matter experts from CDRH, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency(MHRA), and Health Canada (HC).
Sharing information and working in partnership to address issues of mutual interest and concern ultimately allows patients timely access to safe, effective, and high-quality medical devices.