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199:, complaint investigations, audits of recalls, 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
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232:
The Office of
Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center
190:
It is organized into five regions - Northeast (NER), Central (CER), Southeast (SER), Southwest (SWR) and
Pacific (PAR). Each region is structured into district and resident post offices. There are a total of 20 district offices, nineteen of which handle both imported and domestic products and one
146:(FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
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The final branch is an
Administrative Branch which handles budgeting, some aspects of payroll, and other administrative tasks. Regional and national regulatory experts are often located at district offices, but are not administratively part of those offices.
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The FDA Office of
Regulatory Affairs is responsible for the enforcement of federal legislation and serves in a regulatory capacity to ensure health related products are accurately and informatively represented to the public, effective, and safe.
194:
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, issuance of the
191:
import only district (Southwest Import, referred to as "SWID"). Districts, with the exception of the
Southwest Imports District (SWID), are referred to by a three letter name followed by "DO", such as MIN-DO for Minneapolis District.
211:, 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
236:
ORA operations are generally conducted according to the
Compliance Program Guidance Manual (CPGM), Investigations Operations Manual (IOM), and the Regulatory Procedures Manual (RPM).
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The districts also include resident posts, typically in major cities or at major border crossings. These are generally only
Investigations Branch staff.
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The district offices also include a
Compliance Branch. Compliance Officers handle the administrative authorities used in inspections, such as issuing
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222:. They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.
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The Office of
Regulatory Affairs has legislative and regulatory authority for the specified health related products:
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FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
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233:(FCC) and the Winchester Engineering and Analytical Center (WEAC).
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U.S. FDA Medical Device Quality Systems Regulation/Design Controls
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278:. U.S. Food & Drug Administration. 22 September 2021.
555:. U.S. Food & Drug Administration. 27 February 2023.
472:. U.S. Food & Drug Administration. 21 November 2022.
454:. U.S. Food & Drug Administration. 23 February 2023.
320:. U.S. Food & Drug Administration. 20 December 2022.
306:. U.S. Food & Drug Administration. 24 February 2023.
591:. U.S. Food & Drug Administration. 17 January 2023.
537:. U.S. Food & Drug Administration. 2 November 2022.
573:. U.S. Food & Drug Administration. 2 August 2021.
418:. U.S. Food & Drug Administration. 10 March 2023.
390:. U.S. Food & Drug Administration. 5 August 2022.
292:. U.S. Food & Drug Administration. 23 April 2019.
404:. U.S. Food & Drug Administration. 8 March 2023.
362:. U.S. Food & Drug Administration. 8 March 2023.
348:. U.S. Food & Drug Administration. 3 March 2023.
334:. U.S. Food & Drug Administration. 6 March 2023.
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254:"Office of Global Regulatory Operations and Policy"
55:"Office of Global Regulatory Operations and Policy"
376:. U.S. Food & Drug Administration. March 2023.
891:Title 21 of the Code of Federal Regulations (CFR)
845:Family Smoking Prevention and Tobacco Control Act
820:Office of Global Regulatory Operations and Policy
128:Office of Global Regulatory Operations and Policy
711:U.S. FDA International Inspections & Travel
502:"U.S. Public Health Service Commissioned Corps"
721:U.S. FDA Medical Device Quality Systems Manual
207:. Some are also commissioned officers of the
1069:Criticism of the Food and Drug Administration
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567:"U.S. FDA Compliance Program Guidance Manual"
8:
795:Center for Food Safety and Applied Nutrition
780:Center for Biologics Evaluation and Research
508:. U.S. Public Health Service. Archived from
1079:History of the Food and Drug Administration
915:Title 21 of the United States Code (U.S.C.)
585:"U.S. FDA Investigations Operations Manual"
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810:National Center for Toxicological Research
785:Center for Devices and Radiological Health
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304:"U.S. FDA Vaccines, Blood & Biologics"
549:"U.S. FDA Field Science and Laboratories"
106:Learn how and when to remove this message
790:Center for Drug Evaluation and Research
603:"U.S. FDA Regulatory Procedures Manual"
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609:. U.S. Food & Drug Administration.
490:. U.S. Food & Drug Administration.
436:. U.S. Food & Drug Administration.
430:"U.S. FDA ORA Offices & Divisions"
388:"U.S. FDA Radiation-Emitting Products"
260:. U.S. Food & Drug Administration.
175:Radiation-Emitting Electronic Products
42:Please improve this article by adding
7:
855:Federal Food, Drug, and Cosmetic Act
466:"U.S. FDA Inspection Observations"
416:"U.S. FDA Animal & Veterinary"
14:
815:Office of Criminal Investigations
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290:"U.S. FDA Regulatory Information"
144:U.S. Food and Drug Administration
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553:U.S. FDA Science & Research
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879:Title 21 regulations and rules
865:Prescription Drug User Fee Act
805:Center for Veterinary Medicine
332:"U.S. FDA Dietary Supplements"
272:"Office of Regulatory Affairs"
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860:Food Safety Modernization Act
44:secondary or tertiary sources
1118:Food and Drug Administration
762:Food and Drug Administration
201:Food, Drug, and Cosmetic Act
136:Office of Regulatory Affairs
800:Center for Tobacco Products
484:"Public Health Service Act"
402:"U.S. FDA Tobacco Products"
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706:U.S. FDA Inspection Guides
531:"U.S. FDA Warning Letters"
374:"U.S. FDA Medical Devices"
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1074:FDA Most Wanted Fugitives
850:Modernization Act of 1997
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448:"U.S. FDA Import Program"
205:Public Health Service Act
203:as well as parts of the
870:Pure Food and Drug Act
142:), is the part of the
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31:relies excessively on
1028:Andrew von Eschenbach
903:Federal Register (FR)
452:U.S. FDA for Industry
434:U.S. FDA Organization
276:U.S. FDA Organization
258:U.S. FDA Organization
209:Public Health Service
134:), also known as the
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646:United States portal
488:U.S. FDA Legislation
318:"U.S. FDA Cosmetics"
1062:Society and culture
998:Arthur H. Hayes Jr.
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181:Veterinary Products
163:Dietary Supplements
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948:Walter G. Campbell
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1048:Stephen Hahn
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910:Federal law
632:Food portal
838:Major acts
674:Law portal
516:2011-09-21
240:References
66:newspapers
33:references
773:Divisions
160:Cosmetics
157:Biologics
96:June 2018
1112:Category
764:of the
197:FDA 483
80:scholar
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166:Drugs
87:JSTOR
73:books
126:The
59:news
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