ARTICLE SUMMARY:
The new fiscal year brings a planned reorganization to the agency. Excerpted from Pathways’ Picks October 2: A New Year at FDA, China and US Guidance Docs, and More.
A long-planned reorganization of FDA’s field activities and broader intra-agency coordination officially took effect October 1, the first day of the agency’s fiscal year 2025. The revamp, which was primarily sold as a means to establish a unified Human Foods Program at FDA, streamlines the agency’s inspection organization—previously called the Office of Regulatory Affairs (ORA) and now renamed the Office of Inspections and Investigations (OII). The most direct impact from the reorganization on medtech oversight is device compliance officers who previously worked at ORA have now moved to CDRH. Device center officials say the shift will improve CDRH’s ability to efficiently respond to inspection output and observations. FDA also has a newly established Office of the Chief Medical Officer reporting to the commissioner including a new agency-wide office (Office of Public Health Preparedness and Response) to support emergency preparedness and medical product shortage coordination. In addition, FDA has combined functions to form the new Office of Regulatory and Emerging Science to coordinate regulatory science and preparedness research.