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{{Organization  
{{Organization
|OrganizationName= Office of Global Regulatory Operations and Policy
|OrganizationName=Office of Global Regulatory Operations and Policy
|OrganizationType= Executive Departments (Sub-organization)
|OrganizationType=Executive Departments (Sub-organization)
|Mission= To enforce federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products, ensuring they are safe, effective, and accurately represented to the public. It oversees global regulatory compliance to protect public health both domestically and internationally.
|Mission=To enforce federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products, ensuring they are safe, effective, and accurately represented to the public. It oversees global regulatory compliance to protect public health both domestically and internationally.
|OrganizationExecutive= Deputy Commissioner
|ParentOrganization=Food and Drug Administration
|Employees= 5000 (estimate, including field operations)
|TopOrganization=Department of Health and Human Services
|Budget= Part of the FDA's budget; specific allocation not publicly detailed
|Employees=5000
|Budget=Part of the FDA's budget; specific allocation not publicly detailed
|OrganizationExecutive=Deputy Commissioner
|Services=Inspections; compliance; enforcement; laboratory analysis; global regulatory policy; international collaboration
|Regulations=Oversees enforcement under various acts such as the Federal Food, Drug, and Cosmetic Act
|HeadquartersLocation=39.02886, -76.98316
|HeadquartersAddress=10903 New Hampshire Avenue, Silver Spring, MD 20993
|Website=https://www.fda.gov/about-fda/office-global-regulatory-operations-and-policy
|Website=https://www.fda.gov/about-fda/office-global-regulatory-operations-and-policy
|Services= Inspections; compliance; enforcement; laboratory analysis; global regulatory policy; international collaboration
|ParentOrganization= U.S. Food and Drug Administration, U.S. Department of Health and Human Services
|CreationLegislation=
|Regulations= Oversees enforcement under various acts such as the Federal Food, Drug, and Cosmetic Act
|HeadquartersLocation= 38.893624, -77.025481
|HeadquartersAddress= 10903 New Hampshire Avenue, Silver Spring, MD 20993
}}
}}
[[File:FDA Bldg 32 - Pathway to Main Entrance (5161375442).jpg|thumb|FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.]]
[[File:FDA Bldg 32 - Pathway to Main Entrance (5161375442).jpg|thumb|FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs.]]
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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.
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.


== Legislative and regulatory authority ==
The Office of Regulatory Affairs has legislative and regulatory authority for the specified health related products:
The Office of Regulatory Affairs has legislative and regulatory authority for the specified health related products:


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* Veterinary Products<ref>{{cite web |url=https://www.fda.gov/AnimalVeterinary/ |title= U.S. FDA Animal & Veterinary |date= 10 March 2023 |publisher=U.S. Food & Drug Administration}}</ref>
* Veterinary Products<ref>{{cite web |url=https://www.fda.gov/AnimalVeterinary/ |title= U.S. FDA Animal & Veterinary |date= 10 March 2023 |publisher=U.S. Food & Drug Administration}}</ref>


==Organization==
== Organization ==


It is organized into five regions - Northeast (NER), Central (CER), Southeast (SER), Southwest (SWR) and Pacific (PAR).<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |title= U.S. FDA ORA Offices & Divisions |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> 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 import only district (Southwest Import, referred to as "SWID").<ref>{{cite web |url=https://www.fda.gov/ForIndustry/ImportProgram/ |title= U.S. FDA Import Program |website=U.S. FDA for Industry |date= 23 February 2023 |publisher=U.S. Food & Drug Administration}}</ref> 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.
=== Regions ===
It is organized into five regions:   


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 [[Form FDA 483|FDA 483]], complaint investigations, audits of recalls, collections of samples, and other related tasks.<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/ucm250720.htm |title= U.S. FDA Inspection Observations |website=U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 21 November 2022 |publisher=U.S. Food & Drug Administration}}</ref>  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 [[Federal Food, Drug, and Cosmetic Act|Food, Drug, and Cosmetic Act]] as well as parts of the [[Public Health Service Act]].<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |title= Public Health Service Act |website=U.S. FDA Legislation |publisher=U.S. Food & Drug Administration}}</ref>  Some are also commissioned officers of the [[Public Health Service]],<ref>{{cite web |url= http://www.usphs.gov/ |title= U.S. Public Health Service Commissioned Corps |website= USPHS America's Health Responders |publisher= U.S. Public Health Service |access-date= 2011-09-21 |archive-url= https://web.archive.org/web/20090506174822/http://www.usphs.gov/ |archive-date= 2009-05-06 |url-status= dead }}</ref> 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 [[Office of Criminal Investigations|OCI]], though many criminal investigations are started by ORA referring a case to OCI.
* Northeast (NER)
* Central (CER)
* Southeast (SER)
* Southwest (SWR)


The district offices also include a Compliance Branch.  Compliance Officers handle the administrative authorities used in inspections, such as issuing [[FDA Warning Letter|Warning Letters]].<ref>{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |title= U.S. FDA Warning Letters |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 2 November 2022 |publisher=U.S. Food & Drug Administration}}</ref> They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.
Pacific (PAR). <ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |title= U.S. FDA ORA Offices & Divisions |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> 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 import only district (Southwest Import, referred to as "SWID").<ref>{{cite web |url=https://www.fda.gov/ForIndustry/ImportProgram/ |title= U.S. FDA Import Program |website=U.S. FDA for Industry |publisher=U.S. Food & Drug Administration}}</ref> 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.


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.
=== District offices ===
Each district office consists of three branches reporting to a district director, listed below.  
The districts also include resident posts, typically in major cities or at major border crossings. These are generally only Investigations Branch staff.


The districts also include resident posts, typically in major cities or at major border crossings. These are generally only Investigations Branch staff.
==== Investigations Branch ====
The majority of the staff are part of this branch, which performs routine inspections of manufacturers and imported products, issuance of the [[Form FDA 483|FDA 483]], complaint investigations, audits of recalls, collections of samples, and other related tasks.<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/ucm250720.htm |title= U.S. FDA Inspection Observations |website=U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> These staff are mostly Consumer Safety Officers (CSOs, "Investigators") or Consumer Safety Inspectors (CSIs, "Inspectors"). ORA no longer routinely hires CSIs; most new staff are CSOs. These staff have a variety of administrative authorities and enforce the civil law requirements of the [[Federal Food, Drug, and Cosmetic Act|Food, Drug, and Cosmetic Act]] as well as parts of the [[Public Health Service Act]].<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |title= Public Health Service Act |website=U.S. FDA Legislation |publisher=U.S. Food & Drug Administration}}</ref> Some are also commissioned officers of the [[Public Health Service]],<ref>{{cite web |url= http://www.usphs.gov/ |title= U.S. Public Health Service Commissioned Corps |website= USPHS America's Health Responders |publisher= U.S. Public Health Service }}</ref> 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 [[Office of Criminal Investigations|OCI]], though many criminal investigations are started by ORA referring a case to OCI.


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 (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |date= 27 February 2023 |publisher=U.S. Food & Drug Administration}}</ref>
==== Compliance Branch: ====
Compliance Officers handle the administrative authorities used in inspections, such as issuing [[FDA Warning Letter|Warning Letters]].<ref>{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |title= U.S. FDA Warning Letters |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.


ORA operations are generally conducted according to the Compliance Program Guidance Manual (CPGM),<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 2 August 2021 |publisher=U.S. Food & Drug Administration}}</ref> Investigations Operations Manual (IOM),<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/IOM/ |title= U.S. FDA Investigations Operations Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 17 January 2023 |publisher=U.S. Food & Drug Administration}}</ref> and the Regulatory Procedures Manual (RPM).<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
==== Administrative Branch ====
This branch 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.


=== Field laboratories ===
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 (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref>
Below is the list of the 13 field laboratories operated by the Office of Regulatory Affairs (ORA):
Regional Laboratories:
* [[Northeast Regional Laboratory]] (NERL) - Jamaica, NY
* [[Central Regional Laboratory]] (CRL) - Jefferson, AR
* [[Southeast Regional Laboratory]] (SERL) - Atlanta, GA
* [[Southwest Regional Laboratory]] (SWRL) - Dallas, TX
* [[Pacific Regional Laboratory Northwest]] (PRL-NW) - Bothell, WA
District Laboratories:
* [[Pacific Regional Laboratory Southwest]] (PRL-SW) - Irvine, CA
* [[Mid-Atlantic Laboratory]] (MAL) - Winchester, VA
* [[New England Laboratory]] (NEL) - Bedford, MA
* [[Orlando Laboratory]] (ORDL) - Orlando, FL
* [[San Francisco Laboratory]] (SFL) - Alameda, CA
* [[Kansas City Laboratory]] (KCL) - Lenexa, KS
Specialty Laboratories:
* [[Forensic Chemistry Center]] (FCC) - Cincinnati, OH
* [[Winchester Engineering and Analytical Center]] (WEAC) - Winchester, MA
== Manuals ==
ORA operations are generally conducted according to the:
* Compliance Program Guidance Manual (CPGM),<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
* Investigations Operations Manual (IOM),<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/IOM/ |title= U.S. FDA Investigations Operations Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
* Regulatory Procedures Manual (RPM).<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
==Related==
==References==
==References==
{{reflist}}
{{reflist}}
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