Responsibilities in Regulatory Affairs

The Office of Regulatory Affairs is a division of the Food and Drug Administration. It serves as the FDA's lead office for all field activities and supplies input on such issues as imports, inspections and enforcement policies.



The structure of the ORA is one that is made up of five offices. Those are the offices of Resource Management, Regional Operations, Enforcement, and Criminal Investigations.

Office of Resource Management

• The Office of Resource Management is the lead office of the FDA. It initiates, coordinates and offers specific regulatory agreements to foreign countries. It also supplies policy direction to other agency components in regard to foreign-country agreements.

  The office provides technical input for the ORA quality-assurance program, which assures that consistency and adequacy are brought about by field investigations and inspections. It also develops proposed manpower allocations along with long- and short-term operational plans. The Office of Resource Management identifies management-data requirements for information systems and evaluates field-performance data and overall accomplishments. In addition, it sets up and maintains nationwide storage of data that originate from field offices.

Office of Regional Operations

• This office manages all agency field operations on the associate commissioner's behalf. It develops and issues instructions that affect field activities, and it establishes field-compliance measures based on agency policy. This office also coordinates field consumer-information programs and supplies timely information to the field.

  The office serves as the focal point for the agency in maintaining international regulatory policy and activities that ensure the safety and effectiveness of products that have been imported. It develops recommendations of the associate commissioner's office that relate to agency-enforcement problems.

Office of Enforcement

• This office advises the associate commissioner and other agency officials on compliance issues that impact policy development, implementation and long-range program goals. It also coordinates and evaluates the agency's compliance efforts. The office also promotes agency awareness of the necessity for prompt action to ensure compliance by regulated industries.

  The office also evaluates and coordinates legal actions designed to assure compliance with regulatory policy that meet enforcement objectives. In addition, the Office of Enforcement resolves appeals regarding compliance issues.

Office of Criminal Investigations

• This office was created to provide the FDA with an entity to conduct and coordinate criminal investigations. Agents of this office use federal law-enforcement techniques when investigating suspected criminal violations of federal statutes. It concentrates on the violations that may present a significant danger to public health.

  In addition, it investigates other activities such as the manufacture and sale of unapproved drugs, any type of fraud pertaining to the industry, product tampering and adulteration.