Office of Regulatory Affairs

The Office of Regulatory Affairs (ORA) is the part of the United States FDA [1]that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates.

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Organization

It is organised around 5 regions - Northeast (NER), Central (CER), Southeast (SER), Southwest (SWR) and Pacific (PAR). Each region is further divided into district offices. There are a total of 20 district offices, nineteen of which handle both imported and domestic products and one import only district (Southwest Import, referred to as "SWID"). Districts, with the exception of SWID, are referred to by a three letter name followed by "DO", such as MIN-DO for Minneapolis District. ORA also includes field laboratories which were historically part of the districts but are now independent entities. There are also specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).

Each district office consists of three branches reporting to a district director. The majority of the staff are part of an Investigations Branch that performs routine inspections of manufacturers and imported products, audits of recalls, complaint investigations, collections of samples, and other related tasks. These staff are mostly Consumer Safety Officers (CSOs, "Investigators") or Consumer Safety Inspectors (CSIs, "Inspectors"). ORA no longer routinely hire CSIs, most new staff are CSOs. These staff have a variety of administrative authorities and enforce the civil law requirements of the Food, Drug, and Cosmetic Act as well as parts of the Public Health Service Act. Some are also commissioned officers of the Public Health Service, but this does not generally affect day to day duties. These staff are generally technical or scientific and are not involved in criminal law enforcement which is handled by a separate branch of FDA called OCI, though many criminal investigations are started by ORA referring a case to OCI.

The district offices also include a Compliance Branch. Compliance Officers handle the administrative authorities used in inspections, such as issuing Warning Letters. They also organizing civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.

The final branch is an Admin Branch which handles budgeting, some aspects of payroll, and other administrative tasks. Regional and national experts are often located at district offices, but are not administratively part of those offices.

The districts also include resident posts, typically in major cities or at major border crossings. These are generally only Investigations Branch staff.

The ORA attempts to inspect all manufacturers of regulated items about once every two years. Other inspections, such as monitoring of clinical trials, are specifically initiated by headquarters and do not follow a set timeframe.

ORA operations are generally conducted according to the Investigations Operations Manual (IOM,available online) or a compliance program some available online.

• Shows structure of FDA
• list of FDA field offices