FDA Launches New ORA Structure to Align Inspections With Expertise

Regulatory NewsRegulatory News | 15 May 2017 |  By 

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

The move, part of FDA's program alignment, is aimed at more closely aligning the agency's inspection efforts with the various products it regulates.

"Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes.

Under the agency's previous regional model, ORA was organized across five regional offices and 20 district offices.

Now, the agency is replacing the five regional offices—Central, Pacific, Northeast, Southeast and Southwest—with seven product or operations aligned offices:

  • Office of Bioresearch Monitoring Operations (OBIMO) – Map, Fact Sheet
  • Office of Biological Products Operations (OBPO) – Map, Fact Sheet
  • Office of Medical Device and Radiological Health Operations (OMDRHO) – Map, Fact Sheet
  • Office of Pharmaceutical Quality Operations (OPQO) – Map, Fact Sheet
  • Office of Human and Animal Food Operations (OHAFO) – Map, Fact Sheet
  • Office of Enforcement and Import Operations (OEIO) – Map, Fact Sheet
  • Tobacco Operations Program – Map, Fact Sheet

Each office, with the exception of the Tobacco Operations Program, is further broken up into two or more regional divisions, which in turn will be served by the agency's 20 existing districts and 13 field laboratories.

According to FDA, the field laboratories will also be aligned by product area, focusing on food, medical products and tobacco, or both.

In March, FDA spokesperson Lyndsay Meyer told Focus the agency will not be closing any offices, and that none of ORA's staff would lose their jobs or be asked to relocate as a result of the restructuring.



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