FDA Regulatory Affairs Office Restructured to Respond to Growing Industry Globalization

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and keep pace with increasingly global operations. The restructuring will also better position ORA to address new legislative authorities included in the FDA Safety and Innovation Act (FDASIA), signed into law this summer, which boosts supply chain oversight and inspection authority while allowing for risk-based approaches to both — major changes that call for “new strategies” and enhanced coordination across the office, according to an agency fact sheet on the ORA reorganization.
Devices & Diagnostics Letter