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        Inspection References

Field Management Directives

                        
                


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          Inspection References
          Field Management DirectivesInspection References Field Management Directives
  	
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    PrintThe FDA’s Field Management Directives (FMD) are public-facing directives regarding the management of Office of Regulatory Affairs (ORA) field activities that fall outside the scope of other manuals or procedural documents.  They were originally intended to communicate field policy information from headquarters to the field. The scope was later broadened to include both policy and process information. The directives continue to provide field managers with instructions on the management of field activities in both program and operational areas. The first manual providing guidance to field staff was implemented in 1970 and titled Field Policy Directives. By the end of 1972, the manual's title was changed to Field Management Directives. FMDs are issued on the authority of the Associate Commissioner for Regulatory Affairs (ACRA) and approved by an Assistant Commissioner in ORA.

All Current Field Management Directives

NUMBER
			SUBJECT
			AREA
			FMD DATE
			WEB POSTING DATE
			STATUS13
			International Travel
			Operations Management
			03/16/09
			
			Revised13 Att. A
			Memo - Justification for Late Submission of International Travel
			Operations Management
			11/01/02
			
			Revised13 Att. B
			Memo - Justification for Two or More Travelers
			Operations Management
			11/01/02
			
			Revised13 Att. C
			Model Letter of Invitation
			Operations Management
			11/01/02
			
			Revised13 Att. D
			Model Letter of Acceptance
			Operations Management
			11/01/02
			
			Revised13 Att. E
			General Information about FDA Employee Who Attend, Participate in or Speak at Non-Federal Meetings, Conferences, and Symposiums
			Operations Management
			11/01/02
			
			Revised13 Att. F
			Sponsor Certification
			Operations Management
			11/01/02
			
			Revised13A
			Foreign Inspection Program
			Operations Management
			10/05/10
			
			Revised13A Att. A
			Request for Nomination to the FDA International Inspection Cadre
			Operations Management
			03/16/09
			
			Revised13A Att. B
			Criteria Required for Nomination to the FDA International Inspection Cadre
			Operations Management
			03/16/09
			
			Revised15
			Product Shortage Communication
			Operations Management
			07/31/12
			09/24/12
			New29
			Implementing the FDA/National Oceanic & Atmospheric Administration (NOAA) MOU - FMD#-029
			DACRA
			10/31/11
			
			New30
			ORA Program Committee
			Operations Management
			01/05/10
			
			Revised30A
			ORA/CFSAN Human Food Program Committee
			Office of Human and Animal Food Operations (OHAFO)
			08/31/2020
			09/012020
			New30B
			ORA/CVM Animal Food Program Committee
			Office of Human and Animal Food Operations (OHAFO)
			08/31/2020
			09/01/2020
			New37
			ORA Procedures for Responding to Foreign Visitor or Information Requests
			Operations Management
			03/25/10
			
			Revised50
			State Correspondence
			State Program Management
			05/02/11
			
			Revised56
			ORA Weekly Management Review
			Operations Management
			04/05/10
			
			Revised76
			State Contracts-Evaluation of Inspectional Performance
			State Program Management
			08/22/2023
			
			Revised86
			Establishment Inspection Report Conclusions and Decisions
			Operations Management
			12/14/2022
			12/14/2022
			Revised127
			Employee Requested Transfers
			Operations Management
			01/04/13
			
			Revised134
			Pesticide Coordination Teams
			Operations Management
			06/30/94
			
			Revised135
			Pre-operational Reviews of Manufacturing Facilities
			Operations Management
			11/13/09
			
			Revised137
			Badge Retirement Policy
			Operations Management
			04/01/17
			03/28/17
			Revised145
			Procedure for Release of Establishment Inspection Report to the Inspected Establishment
			Operations Management
			07/31/19
			08/26/19
			Revised147
			Communicating Laboratory Analytical Findings for Food Products and Environmental Samples Directive
			Human and Animal Food Operations and Office of Regulatory Sciences
			05/04/2020
			05/11/2020
			Revised149
			Procedures for Requesting ORA International Technical Assistance or Site Visits
			Operations Management
			03/25/10
			
			Original152
			Produce Safety Dispute Mitigation and Resolution Procedures
			Operations Management
			01/31/19
			02/04/19
			OriginalDIR-000088
			Investigations of Facilities engaged in the Manufacturing, Packaging, Labeling, and Testing of Medical Products that may be subject to an Emergency Use Authorization (EUA)
			Office of Medical Products and Tobacco Operations (OMPTO)
			03/17/21
			03/25/21
			New

                                                                                  Content current as of:
      01/18/2024Field Management Directives                
                          

                        


                        Canceled FMDs
 
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