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  1. Office of Regulatory Affairs

ORA Overview

ORA is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 13 laboratories throughout the United States.

As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through:

  • Inspections of firms and plants producing FDA-regulated products
  • Investigations of consumer complaints, emergencies and criminal activity
  • Enforcement of FDA regulations
  • Sample collection and analysis
  • Review of imported products

ORA is committed to quality and continual improvement, and maintains oversight of the industries FDA regulates, including:

  • Foods and Veterinary Medicine
  • Medical Products
  • Tobacco  

ORA efforts in these program areas include:

  • Collaborating with all FDA Product Centers and federal, state, local, tribal, territorial and foreign regulatory public health counterparts
  • Implementing new authorities granted by legislation
  • Developing regulatory program standards for quality improvements
  • Establishing safety systems and coordinating emergency communications
  • Risk-based monitoring of imported products


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